On July 21, 2011, Emmaus Medical received a loan from Equities First Holdings, LLC (“Equities First”) pursuant to a loan agreement by and between Emmaus Medical and Equities First dated June 9, 2011. Pursuant to the loan agreement, Equities First agreed to lend to Emmaus Medical funds equal to 70% of the current fair market value of 73,550 shares of CellSeed, Inc. owned by Emmaus Medical for the three consecutive trading days for the CellSeed stock. The loan bears interest at 4.5% and any interest payment not received within ten calendar days is subject to a penalty equal to 7% of the amount due. The loan was funded on July 21, 2011 (the “Closing Date”) in the principal amount of $841,728.27 and matures on the third anniversary of the Closing Date. Prepayment of the principal amount of the loan or any interest due is not permitted. As collateral for the loan, Emmaus Medical pledged 73,550 of its shares of CellSeed (the “Collateral”) pursuant to a Pledge Agreement with Equities First in which Emmaus Medical assigned its right, title and ownership interest in the Collateral. Within five business days of Emmaus Medical’s payment of all of its obligations under the loan agreement, Equities First shall reassign all right, title and ownership interest in identical securities, as defined in Internal Revenue Code Section 1058, to Emmaus Medical and redeliver the Collateral.
On July 31, 2011, the Company agreed to terminate the promotional rights agreement for Zorbtive® with EMD Serono and after that date will no longer promote Zorbtive®.
On August 9, 2011, the Company issued a one-year convertible note in the principal amount of $54,000 which is convertible until the maturity date of the note on into shares of the Company’s common stock at $3.60 per share. The note bears interest at 8% per annum and matures on July 11, 2012. In connection with the issuance of the note, the lender also received three-year warrants to purchase 3,750 shares of the Company common stock with a per share exercise price equal to 75% of the per share fair market value of the Company’s common stock on the date prior to exercise.
In August 2011 and September 2011, the Company issued seven one-year convertible notes totaling $487,600, which bear interest at 8% per annum and mature on the anniversary date of each note. The principal amount plus the unpaid accrued interest due under each of the convertible notes is convertible into shares of the Company’s common stock at $3.60 per share. In connection with the issuance of the notes, the Company issued three-year warrants to purchase a total of 33,486 shares of our common stock, respectively, at a per share exercise price equal to 75% of the per share fair market value of the Company’s common stock on the date prior to exercise.
In August 2011, the Company entered into an Addendum to the Joint Research and Development Agreement with CellSeed. Pursuant to the Addendum, CellSeed and the Company further acknowledged that all obligations of CellSeed corresponding to the Research Agreement payment of $8.5 million and the Individual Agreement payment of $1.5 million will be fully discharged by CellSeed’s delivery of the Package, which delivery shall be documented by written confirmation of acceptance by the Company. The Company is obligated to make the Research Agreement Payment and the Individual Agreement Payment only after the Company’s provides its written confirmation of acceptance of the complete Package to CellSeed.
On September 14, 2011, the Company changed its name from "Emmaus Holdings, Inc." to "Emmaus Life Sciences, Inc."
The following discussion relates to a discussion of the financial condition and results of operations of Emmaus Holdings, Inc. (the “Company”) and its wholly-owned subsidiary Emmaus Medical, Inc., a Delaware corporation (“Emmaus Medical”), and Emmaus Medical’s wholly-owned subsidiaries Newfield Nutrition Corporation, a Delaware corporation (“Newfield”), and Emmaus Medical Japan, Inc., a Japanese corporation (“EM Japan”).
Forward-Looking Statements
This management’s discussion and analysis of financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and the related notes that are included in this Quarterly Report and the audited consolidated financial statements for the years ended December 31, 2010 and 2009 and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in our Current Report on Form 8-K/A originally filed with the Securities and Exchange Commission on July 5, 2011 and as subsequently amended (the “Current Report”).
This Quarterly Report contains forward-looking statements that involve substantial risks and uncertainties. All statements other than historical facts contained in this report, including statements regarding our future financial position, capital expenditures, cash flows, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “anticipated,” “believe,” “expect, “plan,” “intend,” “seek,” “estimate,” “project,” “could,” “may,” and similar expressions are intended to identify forward-looking statements. These statements include, among others, information regarding future operations, future capital expenditures, and future net cash flow. Such statements reflect our management’s current views with respect to future events and financial performance and involve risks and uncertainties, including, without limitation, our ability to raise additional capital to fund our operations, obtaining FDA and other regulatory approval for our drug products, successful completion of our clinical trials, our ability to achieve regulatory approval for our L-glutamine treatment for sickle cell disease (“SCD”), our ability to commercialize our L-glutamine treatment for SCD; our reliance on third party manufacturers for our drug products, market acceptance of our products, our dependence on licenses for certain of our products, our reliance on the expected growth in demand for our products, exposure to product liability and defect claims, development of a public trading market for our securities, and various other matters, many of which are beyond our control.
Actual results may vary materially and adversely from those anticipated, believed, estimated or otherwise indicated should one or more of these risks or uncertainties occur, or should underlying assumptions prove to be incorrect, or if any of the risks or uncertainties described elsewhere in this report or in the “Risk Factors” section included as a part of Item 2.01 of the Current Report occur. Consequently, all of the forward-looking statements made in this filing are qualified by these cautionary statements and there can be no assurance of the actual results or developments.
Company Overview
Pursuant to an Agreement and Plan of Merger dated April 21, 2011 (the “Merger Agreement”), by and among the Company, AFH Merger Sub, Inc., a wholly-owned subsidiary of the Company (“AFH Merger Sub”), AFH Holding and Advisory, LLC, and Emmaus Medical, Emmaus Medical merged with and into AFH Merger Sub on May 3, 2011 with Emmaus Medical continuing as the surviving entity (the “Merger”). Upon the closing of the Merger, the Company changed its name from “AFH Acquisition IV, Inc.” to “Emmaus Holdings, Inc.”
Upon consummation of the Merger on May 3, 2011, (i) each outstanding share of Emmaus Medical common stock was exchanged for 29.48548924976 shares of our common stock, (ii) each outstanding Emmaus Medical option and warrant, which was exercisable for one share of Emmaus Medical common stock, was exchanged for an option or warrant, as applicable, exercisable for 29.48548924976 shares of our common stock; and (iii) each outstanding convertible note of Emmaus Medical, which was convertible for one share of Emmaus Medical common stock, was exchanged for a convertible note exercisable for 29.48548924976 shares of our common stock. As a result of the Merger, holders of Emmaus Medical common stock, options, warrants and convertible notes received 20,628,305 shares of our common stock (excluding 47,178 shares held by stockholders who exercised dissenters’ rights in connection with the Merger), options and warrants to purchase an aggregate of 326,508 shares of our common stock, and convertible notes to purchase an aggregate of 271,305 shares of our common stock. Securityholders of Emmaus Medical held 85% of our issued and outstanding common stock on a fully diluted basis upon the closing of the Merger. Immediately after the closing of the Merger, we had 24,378,305 (excluding 47,178 shares held by stockholders who exercised dissenters’ rights) shares of common stock, no shares of preferred stock, options to purchase 23,590 shares of common stock, warrants to purchase 302,918 shares of common stock and convertible notes exercisable for 271,305 shares of common stock issued and outstanding.
We develop and commercialize treatments and therapies for rare diseases and are primarily focused on the late-stage development—currently in Phase III clinical trials with the FDA — of the amino acid L-glutamine as a prescription drug for the treatment of SCD. To a lesser extent, we are also engaged in the marketing and sale of NutreStore® [L-glutamine powder for oral solution], which has received FDA approval, as a treatment for short bowel syndrome (“SBS”). Prior to July 31, 2011, we also promoted Zorbtive® [somatropin (rDNA origin) for injection], an FDA approved treatment for SBS. Our indirect wholly owned subsidiary, Newfield Nutrition Corporation, sells L-glutamine as a nutritional supplement under the brand name AminoPure® through retail stores in multiple states and via importers and distributors in Japan and Taiwan. Since inception, we have generated minimal revenues from the sale and/or promotion of NutreStore®, Zorbtive® and AminoPure®. We also own a minority interest in CellSeed, Inc. (“CellSeed”), a Japanese company listed on the JASDAQ NEO market in Tokyo, engaged in research and development, manufacture and sale of temperature-responsive cell culture equipment. Emmaus Medical, LLC was organized on December 20, 2000. In October 2003, Emmaus Medical, LLC conducted a reorganization and merged with Emmaus Medical, Inc., a Delaware corporation originally incorporated in September 2003.
Our future capital requirements are substantial and may increase beyond our current expectations depending on many factors including: the duration and results of the clinical trials for our various products going forward; unexpected delays or developments in seeking regulatory approvals; the time and cost in preparing, filing, prosecuting, maintaining and enforcing patent claims; other unexpected developments encountered in implementing our business development and commercialization strategies; the outcome of litigation, if any; and further arrangements, if any, with collaborators. Until we can generate a sufficient amount of product revenue, if ever, future cash needs are expected to be financed through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. As of June 30, 2011, we had an accumulated deficit since inception of $15.6 million and cash and cash equivalents of $0.4 million. Since inception we have had minimal revenues and have had to rely on funding from sales of equity securities and borrowings from officers and stockholders. Currently, we estimate we will need approximately $5.5 million to complete our Phase III clinical trial and $400,000 to obtain regulatory approval of L-glutamine as a therapy for SCD. In addition, we have agreed to pay CellSeed an aggregate of $10.0 million pursuant a Joint Research and Development Agreement (the “Research Agreement”) and an Individual Agreement (the “Individual Agreement”) with CellSeed.
Recent Highlights
In April 2009, the FDA authorized us to begin a larger Phase III clinical trial directed to study L-glutamine as an experimental agent to reduce sickle cell crisis. Patient enrollment began in mid-2010 and as of June 30, 2011, we have signed contracts with 19 sickle cell study sites across the United States and have enrolled 63 patients. We aim to complete Phase III clinical trial enrollment by the end of 2011 or early 2012.
In October 2010, we formed EM Japan and held approximately 97% of the outstanding shares of EM Japan since its formation until March 2011, when we acquired the remaining outstanding shares of EM Japan. EM Japan is now a wholly-owned subsidiary of Emmaus Medical that markets and sells nutritional supplements in Japan and other neighboring regions. EM Japan also manages our distributors in Japan and may also import other medical products and drugs in the future.
In December 2010, we were awarded a five-year contract by the U.S. Department of Veterans Affairs for our NutreStore® product. In October 2007, we became the exclusive sublicensee of US Patent No. 5,288,703 (the “SBS Patent”) for the U.S. market, including the rights to distribute the L-glutamine treatment for SBS under the trademark NutreStore® in the U.S. and commercially launched NutreStore® in June 2008. Internationally, we are in the last stages of seeking approval to market NutreStore® in Hong Kong and have received a Certificate of Free Sale from the FDA to export NutreStore® to Hong Kong. Previously, we promoted Zorbtive® in the United States pursuant to a promotional rights agreement with EMD Serono, Inc. We terminated the agreement effective July 31, 2011 and no longer promote Zorbtive®.
In March 2011, prior to the Merger, Emmaus Medical completed a private placement of shares of its common stock in which it raised gross proceeds of $1.2 million. During the same month, we received our first order for AminoPure from Taiwan.
We sell L-glutamine as a nutritional supplement under the brand name AminoPure® through our wholly-owned subsidiary Newfield Nutrition Corporation. The product is currently sold through retail stores in multiple states and via importers and distributors in Japan and Taiwan. As part of the growth strategy, Newfield Nutrition is focused on adding additional distributors both domestically and internationally.
Financial Overview
Revenue
As noted above, we are still in the development stage. Since our inception in 2000, we have had limited revenue from the sale of NutreStore®, an FDA approved prescription drug to treat SBS, and AminoPure®, a nutritional supplement. We have funded
operations principally through debt financings and issuance of common stock. Emmaus Medical’s operations to date have been primarily limited to organizing and staffing, licensing and promoting products for SBS, outsourcing distribution and sales activities, developing clinical trials for sickle cell treatment, establishing manufacturing for products and maintaining and improving its patent portfolio.
Currently, we generate revenue through sale of NutreStore® [L-glutamine powder for oral solution] as a treatment for SBS as well as AminoPure® as a nutritional supplement Pursuant to the sublicense agreement for the SBS Patent, we are required to pay a royalty of 10% of adjusted gross sales of NutreStore® to Cato Holding Company (“Cato”), the sublicensor, with a required minimum royalty of $30,000 in 2008 and $70,000 in 2009. There was no required minimum royalty in 2010 and thereafter, other than 10% royalty of adjusted gross sales. Management expects that any revenues generated will fluctuate from quarter to quarter as a result of the timing and amount.
Research and Development Expenses
Research and development costs consist of expenditures for new products and technologies, which primarily involve fees paid to the contract research organization (CRO), payroll-related expenses, study site payments, consultants, activities related to regulatory filings, manufacturing development costs and other related supplies. Product candidates in late stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of late stage clinical trials. We plan to increase our research and development expenses for the foreseeable future as we seek to complete development of our most advanced product candidate, the amino acid L-glutamine as a prescription drug for the treatment of SCD. Currently, we estimate we will need approximately $5.5 million to complete our Phase III clinical trial.
Expenses related to the Phase III clinical trial are based on estimates of the services received and efforts expended pursuant to contracts with study sites and the CRO that conducts and manages the clinical trial on our behalf. We expect to incur increased research and development expenses as we continue to enroll patients in the Phase III clinical trial for sickle cell disease. The most significant clinical trial expenditures are related to the CRO costs and the payment for study sites. The contract with the CRO is based on time and material whereas the study site agreements are based on per patient costs as well as other pass-through costs including but not limited to start-up costs and institutional review board (IRB) fees. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. Management estimates the expenses based on the time period over which the services will be performed and the level of effort to be expended in each period. Although we do not expect the estimate to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and result in us reporting amounts that are higher or lower in any particular period.
While we currently are focused on advancing the sickle cell clinical trials, future research and development expenses will depend on any new products or technologies that may be introduced in the pipeline. In addition, we cannot forecast with any degree of certainty which product candidate(s) may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
At this time, due to the inherently unpredictable nature of the drug development process and the interpretation of the regulatory requirements, we are unable to estimate with any certainty the costs we will incur in the continued development of the sickle cell treatment and other clinical programs. Clinical development timelines, the probability of success and development costs can differ materially from expectations. The current estimated cost to complete the Phase III clinical trial is $5.5 million, which is based on the assumptions that the total number of trial sites does not increase and we remain on the projected timeline. Should the total number of trial sites need to be increased or the timeline have to be moved out further than what is planned, there will be an increase in costs associated with the additional time and effort required by the CRO and company staff.
The drug development process to obtain FDA approval is very costly and time consuming. Even with the granting of orphan drug status and fast track designation, the successful development of the L-glutamine treatment for SCD is uncertain and subject to a number of risks including those described in Item 1A of the Current Report under the caption “Risk Factors.”
The L-glutamine treatment for SCD is investigational in nature and has not received FDA approval. In order to grant marketing approval, the FDA must conclude that the clinical data establishes the safety and efficacy of the L-glutamine treatment for SCD and that the manufacturing processes and controls are adequate. Despite our efforts, the L-glutamine treatment for SCD may not be proven safe and effective in clinical trials, or meet applicable regulatory standards. We are focused on completing the Phase III clinical trial and submitting the new drug application (NDA) to the FDA for consideration. As a result of the uncertainties discussed above, the uncertainty associated with clinical trial enrollment and the risks inherent in the development
process, we are unable to determine the duration and completion of costs or when, and to what extent, we will generate revenues from the commercialization and sale of the L-glutamine treatment for SCD. Development timelines, probability of success and development costs vary widely.
In connection with our agreements with CellSeed related to the development of corneal cell sheet technology in U.S., we believe that the cost to develop this technology is approximately $13 million, which includes the $10 million in payments we have agreed to make to CellSeed pursuant to the Joint Research and Development Agreement and Individual Agreement, and $3 million in research and development costs. Such estimate includes the cost of obtaining FDA approval for the cornea cell sheets. We have assumed that we will need biologic approval of the FDA for the cornea cell sheets, rather than pharmaceutical approval, and that we will only have to run a small trial here in the U.S. to test the safety and efficacy of the corneal cell sheets because we believe that we will be able to submit, and the FDA will accept, the data regarding corneal cell sheets submitted to the EMEA. We estimate that we will need another $2 million to commercialize the corneal cell sheet technology. Due to abundant data available for cornea treatment using this technology, we anticipate it will be two to three years before we can commercialize this product in U.S. For heart treatments, we plan to participate in a multi-center international study within the next two years and anticipate that we will be able to commercialize these products in about five years. We currently do not have an estimate of the estimated costs to develop and commercialize cardiac cell sheets.
No research and development costs are associated with the SBS treatment.
General and Administrative Expenses
General and administrative expenses consist principally of salaries and related costs for personnel in executive, finance, business development, information technology, marketing, and legal functions. Other general and administrative expenses include facility costs, patent filing costs, and professional fees for legal, consulting, auditing and tax services.
Inventories
Inventories consist of finished goods and are valued based on first-in, first-out and at the lesser of cost or market value. All of the purchases during the six months ended June 30, 2011 and 2010 for the Company were from two vendors.
Results of Operations
| | Three Months Ended June 30, | | | Six Months Ended June 30, | | | From December 20, 2000 (date of inception) to June 30, | |
| | 2011 | | | 2010 | | | 2011 | | | 2010 | | | 2011 | |
| | (unaudited) | | | (unaudited) | | | (unaudited) | | | (unaudited) | | | (unaudited) | |
Sales | | | 100,101 | | | | 19,847 | | | | 159,569 | | | | 69,394 | | | | 534,068 | |
Sales Return | | | (2,043 | ) | | | (20,130 | ) | | | (2,298 | ) | | | (23,888 | ) | | | (32,655 | ) |
Revenues | | | 98,058 | | | | (283 | ) | | | 157,271 | | | | 45,506 | | | | 501,413 | |
Cost of goods sold | | | 45,588 | | | | 7,882 | | | | 70,689 | | | | 30,415 | | | | 296,723 | |
Scrapped inventory | | | — | | | | — | | | | — | | | | — | | | | 235,537 | |
Total cost of goods sold | | | 45,588 | | | | 7,882 | | | | 70,689 | | | | 30,415 | | | | 532,260 | |
Gross profit (loss) | | | 52,470 | | | | (8,165 | ) | | | 86,582 | | | | 15,091 | | | | (30,847 | ) |
| | | | | | | | | | | | | | | | | | | | |
Operating expenses | | | | | | | | | | | | | | | | | | | | |
Research and development | | | 337,889 | | | | 236,547 | | | | 648,652 | | | | 458,493 | | | | 5,548,304 | |
Selling | | | 174,185 | | | | 168,310 | | | | 375,696 | | | | 293,352 | | | | 2,177,904 | |
General and administrative | | | 1,478,786 | | | | 400,563 | | | | 2,126,611 | | | | 806,984 | | | | 7,739,351 | |
| | | 1,990,860 | | | | 805,420 | | | | 3,150,959 | | | | 1,558,829 | | | | 15,465,559 | |
Loss from operations | | | (1,938,390 | ) | | | (813,585 | ) | | | (3,064,377 | ) | | | (1,543,738 | ) | | | (15,496,406 | ) |
| | | | | | | | | | | | | | | | | | | | |
Other income (expense) | | | | | | | | | | | | | | | | | | | | |
Interest income | | | 10,169 | | | | 9,382 | | | | 16,614 | | | | 18,391 | | | | 101,848 | |
Interest expense | | | (18,864 | ) | | | (11,893 | ) | | | (30,675 | ) | | | (23,843 | ) | | | (420,668 | ) |
| | | (8,695 | ) | | | (2,511 | ) | | | (14,061 | ) | | | (5,452 | ) | | | (318,820 | ) |
Loss before income taxes | | | (1,947,085 | ) | | | (816,096 | ) | | | (3,078,438 | ) | | | (1,549,190 | ) | | | (15,815,226 | ) |
Income taxes | | | 34,667 | | | | (1,250 | ) | | | (268,411 | ) | | | — | | | | (470,592 | ) |
Net loss | | | (1,981,752 | ) | | | (814,846 | ) | | | (2,810,027 | ) | | | (1,549,190 | ) | | | (15,344,634 | ) |
Net Loss per common share | | | (0.09 | ) | | | (0.04 | ) | | | (0.13 | ) | | | (0.08 | ) | | | | |
Weighted average common shares outstanding | | | 23,077,289 | | | | 19,288,138 | | | | 21,678,616 | | | | 19,288,138 | | | | | |
Three Months Ended June 30, 2011 and 2010
Net Operating Losses. Net operating losses increased $1.2 million, or 150%, from $0.8 million to $2.0 million for the three months ended June 30, 2010 and 2011, respectively, and we expect to continue to generate losses as we progress toward the commercialization of product candidates. The increase in operating losses is primarily a result of increased operating expenses as discussed below. As of June 30, 2011, we had an accumulated deficit of approximately $15.3 million. Losses, partially offset by revenue from commercialized products, will continue as we advance our sickle cell treatment toward regulatory approval and potential commercialization. As a result, we anticipate that we will continue to incur net losses and be unprofitable for the foreseeable future. There can be no assurance that we will ever operate at a profit, even if all of our products are commercialized.
Revenues. Sales increased $80,254, or 404%, from $19,847 to $100,101 for the three months ended June 30, 2010 and 2011, respectively. Sales increased more than unusual for this period due to Newfield’s sale of $50,000 of AminoPure® to Johnson Chemical Pharmaceutical Works Co., its new Taiwan distributor, in the three months ended June 30, 2011. This contributed to an increase in sales of about 300% for the AminoPure® product. In addition, EM Japan generated approximately $20,000 in sales of AminoPure® during this period as compared to no sales in 2010 when EM Japan did not exist. These events caused our increase in revenues. In the second quarter of 2010, we experienced a large number of returns due to the expiration of the NutreStore® product. This is the main reason for a negative net revenue figure amount in 2010. The current inventory of NutreStore® is set to expire in April and May of 2014.
Cost of goods sold. Cost of goods sold increased $37,706, or 478%, from $7,882 to $45,588 for the three months ended June 30, 2010 and 2011, respectively. Cost of goods sold increased primarily as a result of increased unit sales of our AminoPure® product as discussed above in the Revenue section. No scrapped inventory expense was realized for the three months ended June 30, 2011 and 2010. As a percentage of revenue, cost of goods sold decreased from 2,785% to 46% for the three months ended June 30, 2010 and 2011, respectively primarily as a result of the increase in sales. All of the purchases during the three months ended June 30, 2011 and 2010 were from one vendor.
Research and Development Expenses. Research and development expenses increased $0.1 million, or 43%, from $0.2 million to $0.3 million for the three months ended June 30, 2010 and 2011, respectively. This increase was primarily due to increased activity in clinical trials. Research and development costs increased in 2011 and consisted of the following increases: $30,240 for CRO costs; $70,227 for study site expenses; and $18,827 for drug manufacture and other costs. Our clinical trial activities began to ramp up beginning in March 2010 which contributed to the increase in costs in the three months ended June 30, 2011. In 2010, we did not have any active sites. The bulk of payments made in 2010 were deposits to the CRO. As of June 30, 2011, there were 19 sites active and recruiting patients and as a result, CRO time and effort increased.
Selling Expenses. Selling expenses slightly increased $5,875 or 3%, from $168,310 to $174,185 for the three months ended June 30, 2010 and 2011, respectively. The increase was primarily due to payroll and travel costs. The selling expense included the cost of distribution, promotion, travel, tradeshows and exhibits for NutreStore®, Zorbtive®, and AminoPure®.
General and Administrative Expenses. General and administrative expenses increased $1.1 million, or 269%, from $0.4 million to $1.5 million for the three months ended June 30, 2010 and 2011, respectively. The increase was largely due to an increase in costs related to increased payroll, legal fees and consulting fees. The Company hired additional professional staff in 2011 which resulted in an increase in payroll expenses of $21,756. We also incurred increased legal and consulting expenses of approximately $901,091 in connection with the Merger in 2011.
We anticipate that general and administrative expenses will continue to increase for, among others, the following reasons:
| ● | as a result of increased payroll, expanded infrastructure and higher consulting, legal, accounting and investor relations costs, and director and officer insurance premiums associated with being a public company; |
| ● | to support research and development activities, which the Company expects to expand as development of our product candidate(s) continue; and |
| ● | to build a sales and marketing team before we receive regulatory approval of a product candidate in anticipation of commercial launch. |
Six Months Ended June 30, 2011 and 2010
Net Operating Losses. Net operating losses increased $1.3 million, or 87%, from $1.5 million to $2.8 million for the six months ended June 30, 2010 and 2011, respectively, and we expect to continue to generate losses as we progress toward the commercialization of product candidates. The increase in operating losses is primarily a result of increased operating expenses as discussed below. Our increase in operating expenses was largely offset by an increase in our income tax benefit of $0.3 million for the six months ended June 30, 2011. The increase in the tax benefit is due to a decrease in the Company’s valuation allowance on deferred tax assets. The Company currently maintains deferred tax assets equal to its deferred tax liability for unrealized gains on available-for-sale investments under the premise that the Company believes it is more likely than no that it will be able to use its deferred tax assets in the event the investment is sold for a gain. As of June 30, 2011, we had an accumulated deficit of approximately $15.3 million. Losses, partially offset by revenue from commercialized products, will continue as we advance our sickle cell treatment toward regulatory approval and potential commercialization. As a result, we anticipate that we will continue to incur net losses and be unprofitable for the foreseeable future. There can be no assurance that we will ever operate at a profit, even if all of our products are commercialized.
Revenues. Sales increased $90,175, or 129.9% from $69,394 to $159,569 for the six months ended June 30, 2010 and 2011, respectively. Sales increased largely due to increases in the number of units sold of our AminoPure® product. The Company had sales of AminoPure® in the amount of $50,000 from its new market, Taiwan in May 2011. There was $2,298 in returns of the NutreStore® product for the six months ended June 30, 2011 as compared to $23,888 for the six months ended June 30, 2010, or 90% decrease. This decrease in returns was the reason for our $111,765 increase in net revenue, or 246%, for the six months ended June 30, 2011 as compared to the six months ended June 30, 2010.
Cost of goods sold. Cost of goods sold increased $40,274, or 132%, from $30,415 to $70,689 for the six months ended June 30, 2010 and 2011, respectively. Cost of goods sold increased primarily as a result of increased unit sales of our AminoPure® product. No scrapped inventory expense was realized for the six months ended June 30, 2011 and 2010. As a percentage of revenue, cost of goods sold decreased from 67% to 45% for the six months ended June 30, 2010 and 2011, respectively primarily as a result of the increase in sales. All of the purchases during the six months ended June 30, 2011 and 2010 were from two vendors.
Research and Development Expenses. Research and development expenses increased $0.2 million, or 41%, from $0.5 million to $0.7 million for the six months ended June 30, 2010 and 2011, respectively. This increase was primarily due to increased activity in clinical trials. Research and development costs increased in 2011 and consisted of the following increases: $70,488 for CRO costs; $109,228 for study site expenses; and $25,591 for drug manufacture and other costs. Our clinical trial activities began to ramp up beginning in March 2010 which contributed to the increase in costs in the six months ended June 30, 2011. In 2010, we did not have any active sites. The bulk of payments made in 2010 were deposits to the CRO. As of June 30, 2011, there were 19 sites active and recruiting patients and as a result, CRO time and effort increased.
Selling Expenses. Selling expenses increased $82,344, or 28%, from $293,352 to $375,696 for the six months ended June 30, 2010 and 2011, respectively. The increase was primarily due to sales, payroll and travel costs. The selling expense included the cost of distribution, promotion, travel, tradeshows and exhibits for NutreStore®, Zorbtive®, and AminoPure®.
General and Administrative Expenses. General and administrative expenses increased $1.3 million, or 164%, from $0.8 million to $2.1 million for the six months ended June 30, 2010 and 2011, respectively. The increase was largely due to an increase in costs related to increased payroll, legal fees and consulting fees. The Company hired additional professional staff in 2011 which resulted in an increase in payroll expenses of $0.1 million. We also incurred increased legal and consulting expenses of approximately $1 million in connection with the Merger in 2011.
Liquidity and Capital Resources
Based on our losses to date, anticipated future revenue and operating expenses and our cash and cash equivalents balance of $0.4 million as of June 30, 2011, the Company does not appear to have sufficient operating capital without raising additional capital. We incurred losses of $2.8 million for the six months ended June 30, 2011 and $3.5 million for the year ended December 31, 2010. We had an accumulated deficit since inception to June 30, 2011 of $15.3 million. We anticipate that we will continue to incur net losses for the foreseeable future as we incur expenses for the development and commercialization of L-glutamine as a prescription drug for the treatment of sickle cell disease and the expansion of corporate infrastructure, including costs associated with being a public company. As a result, we will seek to fund operations through public or private equity or debt financings, loans, including loans from related parties or other sources, such as strategic partnership agreements. As part of this effort, we have received many loans from stockholders as discussed below. Additionally, we raised approximately $1.2 million in a private rights offering of common stock in March 2011. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategies.
Due to the uncertainty of our ability to meet our current operating and capital expenses, in their report on our audited annual financial statements as of and for the years ended December 31, 2010 and 2009, our independent auditors included an explanatory paragraph regarding concerns about our ability to continue as a going concern. Our financial statements contain additional note disclosures describing the circumstances that led to this disclosure by our independent auditors. There is substantial doubt about our ability to continue as a going concern as the continuation and expansion of our business is dependent upon obtaining further financing, successful and sufficient market acceptance of our products, and, finally, achieving a profitable level of operations.
On April 8, 2011, pursuant to a Research Agreement, we agreed to pay CellSeed $8.5 million within 30 days of the completion of all of the following: (i) the execution of the Research Agreement; (ii) the execution of the Individual Agreement; and (iii) CellSeed’s delivery of the Package to us. Pursuant to the Individual Agreement, the Company agreed to pay $1.5 million to CellSeed within 30 days of CellSeed’s delivery of the Package to the Company and a royalty to be agreed upon by the parties. CellSeed may cancel the agreements if we cannot make the payments when required. CellSeed may terminate these agreements with us if we are unable to make timely payments required under the agreements.
In addition to the $10.0 million we have agreed to pay CellSeed, we currently estimate that we will need an additional $5.5 million to complete our Phase III clinical trial and $0.4 million to obtain FDA approval for our L-glutamine treatment for SCD. Our current cash burn rate is approximately $0.4 million per month. Our future capital requirements will be substantial and may increase beyond our current expectations depending on many factors including: the number, duration and results of the clinical trials for our various products going forward; unexpected delays or developments in seeking regulatory approvals; the time and cost in preparing, filing, prosecuting, maintaining and enforcing patent claims; other unexpected developments encountered in implementing our business development and commercialization strategies; the outcome of litigation, if any; and further arrangements, if any, with collaborators. We will rely, in part, on sales of Aminopure® for revenues, which we expect will increase. However, until we can generate a sufficient amount of product revenue, future cash needs are expected to be financed through public or private equity offerings, debt financings, loans, including loans from related parties, or corporate collaboration and licensing arrangements. If we do not receive adequate funding to complete our clinical trials or to obtain FDA approval for our drug, we may have to delay our trial. If we have to delay our trial, we cannot enroll additional subjects which will delay the approval of the study treatment.
Our cash flow from operations is not adequate, but our future capital requirements are substantial and may increase beyond our current expectations depending on many factors including: the duration and results of the clinical trials for our various products going forward; unexpected delays or developments in seeking regulatory approvals; the time and cost in preparing, filing, prosecuting, maintaining and enforcing patent claims; other unexpected developments encountered in implementing our business development and commercialization strategies; the outcome of litigation, if any; and further arrangements, if any, with collaborators. Until we can generate a sufficient amount of product revenue, future cash needs are expected to be financed through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. There can be no assurance of the availability of such capital on terms acceptable (or at all) to us.
For the six months ended June 30, 2011 and during the year ended December 31, 2010, we borrowed varying amounts pursuant to promissory notes, the majority of which has been from our stockholders. As of June 30, 2011 and December 31, 2010, the Company’s promissory notes totaled $1.9 million and $0.9 million, respectively. Of the $1.9 million of promissory notes outstanding as of June 30, 2011, $1.4 million was due to stockholders and all of the amounts outstanding under the notes as of December 31, 2010 were due to stockholders. The promissory notes carry interest from 0% to 10% and except for one promissory note in the principal amount of $0.5 million, the debt is unsecured. Interest on 0% loans was imputed at the incremental borrowing rate of 6% per annum. The net proceeds of the loans were used for working capital.
The table below lists the outstanding loans as of June 30, 2011 and the material terms of our outstanding loans:
Lender | | Loan Type | | Annual Interest Rate | | | Date of loan | | Term of Loan | | Loan Amount (net of discount) | | | Amount Outstanding as of June 30, 2011 | |
Hope Hospice International | | Unconvertible | | | 8 | % | | 1/12/11 | | 2 years | | $ | 200,000 | | | $ | 200,000 | |
Yutaka Niihara | | Unconvertible | | | 6.5 | % | | 1/12/09 | | Due on demand | | $ | 350,000 | | | $ | 350,000 | |
Daniel Kimbell | | Unconvertible | | | 6.5 | % | | 4/27/2009 | | Due on demand | | $ | 20,000 | | | $ | 20,000 | |
Daniel Kimbell | | Unconvertible | | | 6.5 | % | | 5/11/2009 | | Due on demand | | $ | 10,000 | | | $ | 10,000 | |
Nami Murakami | | Convertible | | | 0 | % | | 8/16/2010 | | 5 years | | $ | 18,000 | | | $ | 18,000 | |
Makoto Murakami | | Convertible | | | 0 | % | | 8/16/2010 | | 5 years | | $ | 18,000 | | | $ | 18,000 | |
Kazuo Murakami | | Convertible | | | 0 | % | | 8/16/2010 | | 5 years | | $ | 18,000 | | | $ | 18,000 | |
M’s Support Co. Ltd. | | Convertible | | | 0 | % | | 8/17/2010 | | 5 years | | $ | 18,000 | | | $ | 18,000 | |
Yumiko Takemoto | | Convertible | | | 6 | % | | 11/23/2010 | | 5 years | | $ | 2,000 | | | $ | 2,000 | |
Shigeru Matsuda | | Convertible | | | 6.5 | % | | 1/12/2009 | | 5 years | | $ | 221,895 | | | $ | 254,100 | |
Mitsubishi UFJ Capital III, Limited Partnership | | Convertible | | | 10 | % | | 3/14/11 | | 5 years | | $ | 500,000 | | | $ | 500,000 | |
Yutaka Niihara | | Unconvertible | | | 8 | % | | 6/21/2011 | | Due on demand | | $ | 100,000 | | | $ | 100,000 | |
Yasushi Nagasaki | | Convertible | | | 8 | % | | 6/29/2011 | | 1 year | | $ | 178,483 | | | $ | 178,483 | |
TOTAL | | | | | | | | | | | | | | | | $ | 1,686,583 | |
The loan to the Company from Hope Hospice International is evidenced by a promissory note. Pursuant to the note, interest is payable quarterly with the principal being due and payable on the maturity date. If we fail to make any payment when due under the note or we seek relief under the U.S. Bankruptcy Code or suffer an involuntary petition in bankruptcy or receivership that is not vacated within 30 days, the entire balance of the note is due and payable to the holder.
The loan to the Company from Dr. Niihara made in 2009 is evidenced by a promissory note. Pursuant to the note, interest is payable monthly with principal and any accrued unpaid interest being due upon demand by the holder. If we fail to make a payment within 10 days after the due date, we must pay an additional late fee of 2% of the late interest payment. If we fail to make any payment when due under the note, breach any condition relating to any security for the note (although the note is unsecured), seek relief under the U.S. Bankruptcy Code or suffer an involuntary petition in bankruptcy or receivership that is not vacated within 30 days, the entire balance of the note is due and payable to the holder. Dr. Niihara loaned the Company an additional $100,000 on June 21, 2011. Pursuant to the promissory note evidencing the loan, interest is payable monthly with principal and any accrued unpaid interest being due upon demand by the holder. If we fail to make any payment when due under the note or seek relief under the U.S. Bankruptcy Code or suffer an involuntary petition in bankruptcy or receivership that is not vacated within 30 days, the entire balance of the note is due and payable to the holder.
The loans to the Company from Nami Murakami, Makoto Murakami, Kazuo Murakami and M’s Support Co. Ltd. are evidenced by promissory notes. Pursuant to the notes, interest is payable quarterly with the principal being due and payable on the maturity date. The holder, at his option, may convert the principal amount of the note into shares of our common stock at a conversion price of $3.05 per share. If we fail to make any payment when due under the note or we seek relief under the U.S. Bankruptcy Code or suffer an involuntary petition in bankruptcy or receivership that is not vacated within 30 days, the entire balance of the note is due and payable to the holder.
The loans to the Company from Daniel Kimbell are evidenced by promissory notes. Pursuant to the notes, interest is payable monthly. If we fail to make a payment within 10 days after the due date, we must pay an additional late fee of 2% of the late interest payment. If we fail to make any payment when due under the notes, breach any condition relating to any security for the notes (although the note is unsecured), seek relief under the U.S. Bankruptcy Code or suffer an involuntary petition in bankruptcy or receivership that is not vacated within 30 days, the entire balance of the notes is due and payable to the holder.
The loan to the Company from Mitsubishi UFJ Capital III, Limited Partnership is evidenced by a promissory note. Pursuant to the note, interest accrues at 10% per annum beginning on January 1, 2012. Interest only payments are due monthly with the principal being due and payable on the maturity date. The holder, at any time during the term of the note but no later than one month after the date our shares of common stock are traded on NASDAQ, may convert the principal amount and any accrued interest owing at the time of such conversion into shares of our common stock at $3.05 per share. Upon the conversion of the note, the holder will also receive a warrant to purchase shares of our common stock in an amount equal to 25% of the number of shares received upon the conversion of the note. The exercise price of the warrants will be $3.05 per share. The principal amount of the note is secured by 73,550 shares of common stock of CellSeed owned by Emmaus Medical. If we fail to make any payment when due under the note, seek relief under the U.S. Bankruptcy Code or suffer an involuntary petition in bankruptcy or receivership that is not vacated within 30 days, the entire balance of the note is due and payable to the holder. In addition, the lender may require us to perform all obligations under the note in the event our shares are not traded on NASDAQ on or prior to December 31, 2011 or that any stockholder is engaged in any antisocial activities.
The loan to the Company from Shigeru Matsuda is evidenced by a promissory note. If requested by the lender, we must make quarterly interest only payments. The lender may also allow interest payments to accrue, pursuant to which the unpaid but accrued interest shall be added to the principal. The entire unpaid principal and any accrued interest thereon shall become
immediately due and payable on demand by the holder. The holder, at any time during the term of the note, may convert the principal amount and any accrued interest owing at the time of such conversion into shares of our common stock at $3.05 per share. If we fail to make a payment within 10 days after the due date, we must pay an additional late fee of 2% of the late interest payment. Dr. Niihara and Daniel Kimbell, the former Chief Operating Officer of Emmaus Medical, agreed to be the primary guarantor and secondary guarantor on the note such that in the event we cannot pay the note, Dr. Niihara and Mr. Kimbell, in that order, will make payments due to the lender. If we or the guarantors fail to make any payment due under the terms of the note, or breach any condition relating to any security, security agreement, note, mortgage or lien granted as collateral security for the note, seek relief under the U.S. Bankruptcy Code, or suffer an involuntary petition in bankruptcy or receivership not vacated within 30 days, the entire balance of the note and any interest accrued thereon shall be immediately due and payable to the holder.
The loan to the Company from Yumiko Takemoto is evidenced by a promissory note. Pursuant to the note, interest is payable quarterly with the principal being due and payable on the maturity date. The holder, at his option, may convert the principal amount of the note into shares of our common stock at a conversion price of $3.05 per share. If we fail to make any payment when due under the note or we seek relief under the U.S. Bankruptcy Code or suffer an involuntary petition in bankruptcy or receivership that is not vacated within 30 days, the entire balance of the note is due and payable to the holder.
The loan to the Company from Yasushi Nagasaki is evidenced by a promissory note. The entire principal amount of the note and any outstanding accrued interest is due on the maturity date. The principal amount and any unpaid interest due under the promissory note are convertible into shares of our common stock at $3.60 per share. Mr. Nagasaki received a warrant to purchase 25,000 shares of common stock at an exercise price equal to 75% of the fair market value of the Company’s common stock on the date prior to exercise. If we fail to make a payment within 10 days after the due date, we must pay an additional late fee of 2% of the late interest payment. If we fail to make any payment due under the terms of the note, seek relief under the U.S. Bankruptcy Code or suffer an involuntary petition in bankruptcy or receivership that is not vacated within 30 days, the entire balance of the note is due and payable to the holder.
Cash Flows
Net cash used in operating activities
Net cash flows used in operating activities increased $0.2 million, or 10%, from $1.9 million to $2.1 million for the six months ended June 30, 2010 and 2011, respectively. This increase was primarily due to a $1.5 million increase in operating expenses offset by an increase in the accounts payable outstanding balance of $1.1 million and due to related party of $0.2 million. The increase in operating expenses was a result of the costs associated in preparing for the merger and public offering. The increase in accounts payable was mainly the result of incurred legal expenses payable of $0.5 million and increased consulting expenses payable of $0.5 million related to the public offering. We expect that operating expenses will continue to increase due to costs related to being a publicly reporting company.
Net cash used in investing activities
Net cash flows used in investing activities decreased from $4,630 to $1,494 for the six months ended June 30, 2010 and 2011, respectively, for the purchase of property and equipment.
Net cash from financing activities
Net cash flows from financing activities increased $0.6 million, or 41%, from $1.6 million to $2.2 million for the six months ended June 30, 2010 and 2011, respectively primarily as a result a $0.1 million decrease in the proceeds from the issuance of shares of our common stock and a $0.9 million increase in the proceeds from the issuance of notes payable and convertible notes payable.
A total of $0.1 million of convertible notes payable were converted into shares of our common stock during the six months ended June 30, 2011, compared to $0 for the six months ended June 30, 2010.
Off-Balance-Sheet Arrangements
Since our inception, we have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities or variable interest entities.
Critical Accounting Policies
Management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates.
While our significant accounting policies are more fully described in Note 2 to our financial statements included in this Quarterly Report, we believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating our reported financial results and affect the more significant judgments and estimates that we use in the preparation of our financial statements.
Revenue recognition
The Company recognizes revenue in accordance with the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin (“SAB”) No. 101, Revenue Recognition in Financial Statements (“SAB 101”), as amended by Staff Accounting Bulletin No. 104, Revision of Topic 13 (“SAB 104”).
Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable and collection is reasonably assured.
With prior written approval of the Company, product is returnable only by our direct customers for a returned goods credit, if the product meets any of the following criteria:
| A. | Product expiring within six (6) months of the expiration date printed on the package/container that is in the manufacturer’s original package/container and bears the original label. |
| B. | Expired product that is in the manufacturer’s original package/container and bears the manufacturer’s original label, provided, however, that expired product must be returned within 12 months of the expiration date printed on the package/container. |
| C. | Product shipped directly by the Company that is damaged in transit, subject to Free on Board (“FOB”) Destination, or material shipped in error by the Company. |
| D. | Product that is discontinued, withdrawn, or recalled. |
Credits will only be issued for full cartons only without any missing packets of product. No credit is issued, nor does the Company accept charges or deductions for administrative, handling, or freight charges associated with the return of product to the Company. No credit is issued for product destroyed by anyone other than the Company. Customers must return the product within 60 days of receiving our written approval for the return or the return will not be issued a credit. The amount of the credit provided for returned product is based on the current wholesale acquisition cost of the returned product less 5%. When product is returned, a credit memo is applied to the customer’s current account balance or applied to future purchases. Credit memos expire one hundred eighty (180) days from date issued.
We estimate our sales return based upon our prior sales and return history. Historically, sales returns have been very nominal. The extraordinary sales returns in the six months ended June 30, 2010 were all related to the same batch of NutreStore product produced in 2008 that expired. We continue to monitor our returns and will adjust our estimates based on our actual sales return experience. Based upon our sales return history we will record a reserve for estimated returns during each reporting period.
We are required to pay royalties which are recognized as expense upon sale of the products. the royalty equivalent to 10% of adjusted gross sales is due to CATO on an annual basis. The 10% royalty is calculated at the end of year and accrued on an annual basis.
Share-based payments
We recognize compensation cost for share-based compensation awards during the service term of the recipients of the share-based awards. The fair value of share-based is calculated using the Black-Scholes-Merton pricing model. The Black-Scholes-Merton model requires subjective assumptions regarding future stock price volatility and expected time to exercise, which greatly affect the calculated values. The expected term of awards granted is derived from historical data on awards exercised and post-vesting employment termination behavior. The risk-free rate selected to value any particular grant is based on the U.S. Treasury rate that corresponds to the vesting period of the grant effective as of the date of the grant. The expected volatility is based on the historical volatility of the common stock of comparable publicly traded companies. These factors could change, affecting the determination of stock-based awards expense in future periods.
Marketable securities
Securities available-for-sale are recorded at cost and any increases or decreases in fair market value are recorded as unrealized
gain or loss, net of taxes in accumulated other comprehensive income. We monitor these investments for impairment and make appropriate reductions in carrying values when necessary.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not required for a smaller reporting company.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures, which are designed to ensure that information required to be disclosed in the reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer, or CEO, and Chief Financial Officer, or CFO, as appropriate to allow timely decisions regarding required disclosure.
Based on an evaluation carried out as of the end of the period covered by this quarterly report as restated on September 28, 2011, under the supervision and with the participation of our management, including our CEO and CFO, our CEO and CFO have concluded that, as of the end of such period, our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934) were ineffective as of June 30, 2011. The change in our conclusion as to the effectiveness of our disclosure controls results from the restatement of our financial statements included in this amendment.
Changes in Internal Control Over Financial Reporting
On April 21, 2011, we entered into an agreement and plan of merger with AFH Merger Sub, Inc., our wholly-owned subsidiary, (“AFH Merger Sub”), AFH Holding and Advisory, LLC, and Emmaus Medical, Inc. (“Emmaus Medical”) pursuant to which Emmaus Medical agreed to merge with and into AFH Merger Sub with Emmaus Medical continuing as the surviving entity (the “Merger”). Upon the closing of the Merger on May 3, 2011, the sole business conducted by our company is the business conducted by Emmaus Medical and it subsidiaries and certain of the officers and directors of Emmaus Medical became officers and directors of our company. Also, as a result of the Merger, the internal control over financial reporting utilized by Emmaus Medical prior to the Merger became the internal control over financial reporting of our company
Based on the evaluation of our management as required by paragraph (d) of Rule 13a-15 or 15d-15 of the Exchange Act, we believe that, other than the changes described above, there were no changes in our internal control over financial reporting that occurred during our last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
None.
Any investment in our common stock involves a high degree of risk. Investors should carefully consider the risks described below and all of the information contained in this report before deciding whether to purchase our common stock. Our business, financial condition or results of operations could be materially adversely affected by these risks if any of them actually occur. Our shares of common stock are not currently listed or quoted for trading on any national securities exchange or national quotation system. If and when our common stock is traded, the trading price could decline due to any of these risks, and an investor may lose all or part of his or her investment. Some of these factors have affected our financial condition and operating results in the past or are currently affecting us. This Quarterly Report also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including the risks described below and elsewhere in this report.
Upon the closing of the Merger on May 3, 2011, we (i) became the 100% parent of Emmaus Medical, (ii) assumed the operations of Emmaus Medical and its subsidiaries; and (iii) changed our name from “AFH Acquisition IV, Inc.” to “Emmaus Holdings, Inc.” As a result of the closing of the Merger, there have been material changes from the risk factors disclosed in the “Risk Factors” section of our annual report on Form 10-K for the year ended December 31, 2010. Please refer to the risk factors set forth in Item 2.01 of the Current Report for the risks related to our business post-Merger.
On June 29, 2011, we issued a one-year convertible promissory note to Yasushi Nagasaki, our Chief Financial Officer, in the principal amount of $360,000. The note bears interest at 8% per annum. During the term of the note, the principal and any unpaid interest on the note are convertible at the holder’s option into shares of our common stock at a conversion rate of $3.60 per share. Mr. Nagasaki also received a warrant to purchase 25,000 shares of common stock with an exercise price equal to 75% of the fair market value of the Company’s common stock on the date prior to exercise. The Company recorded a discount on the convertible debt based on the value of warrants granted in the note agreement and a beneficial conversion feature. $58,790 was allocated to the warrants and $122,727 was allocated to the beneficial conversion feature. The note and warrant were offered and issued in reliance upon the exemption from registration pursuant to the exemption from registration provided by Section 4(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Rule 506 promulgated thereunder. Mr. Nagasaki qualified as an “accredited investor,” as defined by Rule 501 under the Securities Act.
None.
On June 29, 2011, we issued a one-year convertible promissory note to Yasushi Nagasaki, our Chief Financial Officer, in the principal amount of $360,000. The note bears interest at 8% per annum. During the term of the note, the principal and any unpaid interest on the note are convertible at the holder’s option into shares of our common stock at a conversion rate of $3.60 per share. Mr. Nagasaki also received a warrant to purchase 25,000 shares of common stock with an exercise price equal to 75% of the fair market value of the Company’s common stock on the date prior to exercise. Such warrants will have an exercise price equal to 75% of the fair market value of the Company’s common stock on the date of conversion. The Company recorded a discount on the convertible debt based on the value of warrants granted in the note agreement and a beneficial conversion feature. $58,790 was allocated to the warrants and $122,727 was allocated to the beneficial conversion feature. The note and warrant were offered and issued in reliance upon the exemption from registration pursuant to the exemption from registration provided by Section 4(2) of the Securities Act and Rule 506 promulgated thereunder. Mr. Nagasaki qualified as an “accredited investor,” as defined by Rule 501 under the Securities Act.
On July 21, 2011, Emmaus Medical received a loan from Equities First Holdings, LLC (“Equities First”) pursuant to a loan agreement with Equities First dated June 9, 2011. Pursuant to the loan agreement, Equities First agreed to lend to Emmaus Medical funds equal to 70% of the current fair market value of 73,550 shares of CellSeed, Inc. owned by Emmaus Medical for
the three consecutive trading days for the CellSeed stock. The loan bears interest at 4.5% and any interest payment not received within ten calendar days is subject to a penalty equal to 7% of the amount due. The loan was funded on July 21, 2011 (the “Closing Date”) in the principal amount of $841,728 and matures on the third anniversary of the Closing Date. Prepayment of the principal amount of the loan or any interest due is not permitted. As collateral for the loan, Emmaus Medical assigned 73,550 of its shares of CellSeed (the “Collateral”) pursuant to a Pledge Agreement with Equities First in which Emmaus Medical assigned its right, title and ownership interest in the Collateral. Within five business days of Emmaus Medical’s payment of all of its obligations under the loan agreement, Equities First shall reassign all right, title and ownership interest in identical securities, ad defined in Internal Revenue Code Section 1058, to Emmaus Medical and redeliver the Collateral. The following constitute events of default under the loan agreement: Emmaus Medical’s failure to pay any obligations when due within ten calendar days of the due date; any inaccuracy of Emmaus Medical’s representations and warranties in the agreement or any other loan document; Emmaus Medical’s default in the performance of any covenant in the loan agreement or any loan document not cured within a reasonable time; any event of default under the Pledge Agreement; the removal of the collateral from a national or international securities exchange, the halting of trading for three business days of the Pledged Collateral or the failure of the Pledged Collateral to be publicly traded on a national or international exchange; Emmaus Medical’s general assignment for the benefit of creditors or consent to the appoint of a receiver or similar official of all of its properties, Emmaus Medical’s written admission of its inability to pay its debts as they mature or Emmaus Medical’s commencement of any action under any federal or state insolvency statute; the Pledge Agreement’s failure to create a valid and perfected first priority security interest in the Pledged Collateral; an action against Emmaus Medical seeking an attachment or similar process against all or any substantial part of Emmaus Medical’s property which results in the entry of an order for relief which remains undismissed or undischarged for 60 days; or the fair market value of the Pledged Collateral shall be less than 80% of the loan principal amount. Upon an event of default, the loan, together with all accrued and unpaid interest, shall be due and payable.
The information included in this Item 5 is provided in accordance with Item 1.01, Item 2.03 and Item 3.02 of Form 8-K.
(a) Exhibits
Exhibit Number | | Description of Document |
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4.1 | | Convertible Promissory Note dated June 29, 2011 issued by the registrant to Yasushi Nagasaki (incorporated by reference to Exhibit 4.8 to the Registration Statement on Form S-1 filed with the Securities and Exchange Commission on July 11, 2011). |
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4.2 | ** | Loan Agreement dated June 9, 2011 by and between Emmaus Medical, Inc. and Equities First Holdings, LLC. |
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4.3 | ** | Pledge Agreement dated June 9, 2011 by and between Emmaus Medical, Inc. and Equities First Holdings, LLC. |
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101.INS | | XBRL Instance Document |
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101.SCH | | XBRL Taxonomy Extension Schema Document |
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101.CAL | | XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF | | XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB | | XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE | | XBRL Taxonomy Extension Presentation Linkbase Document |
* | This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in any filings. |
EMMAUS HOLDINGS, INC.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Emmaus Life Sciences, Inc. |
| | |
Dated: October 5, 2011 | | /s/ Yutaka Niihara |
| By: | Yutaka Niihara, M.D., MPH |
| Its: | President and Chief Executive Officer (principal executive officer and duly authorized officer) |
| | |
| | /s/ Yasushi Nagasaki |
| By: | Yasushi Nagasaki |
| Its: | Chief Financial Officer (principal financial and accounting officer) |