08/14/2026 | Press release | Distributed by Public on 08/14/2026 12:22
Management's Discussion and Analysis of Financial Condition and Results of Operations
In the following discussion, the terms, "we," "us," "our," "Emmaus" or the "Company" refer to Emmaus Life Sciences, Inc. and its direct and indirect subsidiaries.
Forward-Looking Statements
This Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the audited consolidated financial statements and the related notes included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission ("SEC") on March 31, 2026 (the "Annual 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 "anticipate," "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 those set forth in the "Risk Factors" section of the Annual Report, many of which are beyond our control.
Should one or more of these risks or uncertainties occur, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated or otherwise indicated. Consequently, all forward-looking statements made in this Form 10-Q are qualified by these cautionary statements. We undertake no duty to amend or update these statements beyond what is required by SEC reporting requirements.
Company Overview
Endari® was approved for marketing in the United Arab Emirates, or U.A.E, in Qatar, Kuwait, Bahrain, and Oman. Our application for marketing authorization in the Kingdom of Saudi Arabia, or KSA is pending. While the application is pending, the FDA approval of Endari® can be referenced to allow access to Endari® in the KSA on a named-patient basis. In January 2025, Endari® was afforded market exclusivity in the KSA by the KSA's unified purchasing system which extends to all KSA government institutions, including hospitals under the Ministry of Health, Military Hospitals, the National Guard, the Security Forces, and King Faisal Specialty Hospitals and Research Centers.
Endari® is sold in the U.S. through our nonexclusive distributors and in the Middle East North Africa, or MENA, region through exclusive arrangements with local distributors. In December 2025, we entered into a License and Exclusive Distribution Agreement, or License Agreement, with NeoImmuneTech, Inc., or NIT, pursuant to which we granted NIT on the "Effective Date" of May 15, 2026 an exclusive license to our rights to market, sell, and distribute Endari® and any generic equivalents we may develop in sickle cell disease, or the Field, in the U.S. and its territories and possessions and Canada, or the Territory, in exchange for an upfront cash payment, a double digit percentage royalty on NIT's sales of the licensed products and a double digit percentage of any NIT sublicenses of rights to the products. We agreed in the License Agreement to use $1.0 million of the upfront payment paid on the Effective Date to subscribe to purchase shares of NIT capital stock.
In connection with the License Agreement, we and NIT entered into an Exclusive Supply Agreement pursuant to which we agree to supply exclusively to NIT, and NIT agrees, subject to certain exceptions, to purchase exclusively from us all NIT's requirements for the Products in the Field in the Territory at a purchase price based upon our cost of production plus a specified double digit percentage margin.
Prior to the Effective Date, NIT hired selected members of our U.S. sales force and we have entered into a sales services agreement under which NIT renders to us sales and marketing services for Endari® in the Field in the Territory in exchange for our payment of quarterly fees in the low-to-mid six figures. We continued to realize all revenues from sales of the Endari® in the Territory prior to the Effective Date.
Under the License Agreement, each party is entitled to make improvements to the licensed products and to own their respective improvements, subject to the grant of appropriate cross-rights to any such improvements. We retain all rights in the licensed products outside the Field and outside the Territory.
NIT has no experience in marketing brand name or generic pharmaceuticals in the U.S. or elsewhere, and there is no assurance that it will be able to successfully market and distribute Endari® or other licensed products.
For the foregoing reasons, our historical results of operations are unlikely to be an indication of our future performance.
Endari® is reimbursable by the Centers for Medicare and Medicaid Services, and every state provides coverage for Endari® for outpatient prescriptions to all eligible Medicaid enrollees within their state Medicaid programs. Endari® is also reimbursable by many commercial payors. We have agreements in place with the nation's leading distributors, as well as physician group purchasing organizations and pharmacy benefits managers, making Endari® available at selected retail and specialty pharmacies nationwide which are expected to be assigned and assumed by NIT in connection with the Effective Date of the License Agreement. Following the Effective Date of the License Agreement with NIT, our revenues from U.S. operations will depend upon sales of Endari® to NIT under the exclusive supply agreement and on royalties from NIT's sales of Endari® in the Territory.
As of June 30, 2026, our accumulated deficit was $272.1 million, and we had cash and cash equivalents of $2.8 million. Until we can generate sufficient net revenues from Endari® sales or enter into one or more strategic transactions, our future cash requirements are expected to be financed through loans from related parties, third-party loans, public or private equity or debt financings or possible corporate collaboration and licensing arrangements. We are unable to predict if or when we may generate increased net revenues or accomplish strategic transactions.
Results of Operations:
Three months ended June 30, 2026 and 2025
Net Revenues. Net revenues increased by $3.5 million, or 124%, to $6.3 million for the three months ended June 30, 2026, compared to $2.8 million for the three months ended June 30, 2025 due to the recognition of $4.8 million of revenue from the upfront fee and royalties under the License Agreement with NIT, partially offset by a decrease of direct Endari® sales.
Cost of Goods Sold. Cost of goods sold increased by $0.2 million, or 129%, to $0.3 million for the three months ended June 30, 2026, compared to $0.2 million for the three months ended June 30, 2025. The increase was primarily due to higher sales volume, including the deemed sales of 3,000 cartons transferred to NIT upon the Effective Date.
Research and Development Expenses. Research and development expenses were not significant in either prior period.
Selling Expenses. Selling expenses decreased by $0.2 million, or 27%, to $0.5 million for the three months ended June 30, 2026, compared to $0.7 million for the three months ended June 30, 2025. The decrease was mainly due to a decrease of $0.2 million of payroll expense as we transferred our sales force to and entered into a sales service agreement with NIT as a part of the exclusive distribution and licensing arrangement. The sales service agreement was terminated upon the Effective Date. Management expects the U.S. selling expenses to decrease in the future.
General and Administrative Expenses. General and administrative expenses decreased by $0.7 million, or 32%, to $1.6 million for the three months ended June 30, 2026, compared to $2.3 million for the three months ended June 30, 2025. The decrease was due to decreases of $0.2 million in payroll expenses attributable to the reduction in headcount, $0.2 million in professional services expenses, and $0.3 million in one-time settlement fee.
Other Expense. Total other expenses increased by $1.1 million, or 81%, to $2.5 million for the three months ended June 30, 2026, compared to $1.4 million for the three months ended June 30, 2025. The increase was primarily due to decreases of $0.9 million in gain on lease modification and $0.4 million in change in fair value of investments in equity security.
Net Income (Loss). Net income was $1.3 million and net loss $1.1 million for three months ended June 30, 2026 and 2025, respectively. The increase in net income was due to an increase in income from operations partially offset by an increase in other expense.
Six months ended June 30, 2026 and 2025
Net Revenues. Net revenues increased by $3.1 million, or 59%, to $8.3 million for the six months ended June 30, 2026, compared to $5.2 million for the six months ended June 30, 2025 as the Company recognized $4.8 million of revenue from the upfront fee and royalties under the License Agreement, which was partially offset by a decrease of $1.7 million in U.S. sales.
Cost of Goods Sold. Cost of goods sold increased by $0.1 million, or 37%, to $0.5 million for the six months ended June 30, 2026, compared to $0.4 million for the six months ended June 30, 2025. The increase was primarily due to an increase in the manufacturing cost of Endari®.
Research and Development Expenses. Research and development expenses remained consistent from prior period.
Selling Expenses. Selling expenses slightly decreased by $0.1 million, or 6%, to $1.2 million for the six months ended June 30, 2026, compared to $1.3 million for the six months ended June 30, 2025. The decrease was primarily due to decreases of $0.4 million in payroll expense, $0.1 million in distribution fee, partially offset by increase in consulting fee as we transferred our sales force to and entered into a sales service agreement with NIT as part of the exclusive distribution and licensing arrangement discussed above. The sales service agreement was terminated upon the Effective Date, management expects the U.S. selling expenses to decrease in the future.
General and Administrative Expenses. General and administrative expenses decreased by $1.2 million, or 26%, to $3.4 million for the six months ended June 30, 2026, compared to $4.6 million for the six months ended June 30, 2025. The decrease was primarily due to decreases of $0.3 million in payroll expense. $0.1 million in professional services fees, $0.2 million in rent expense, and $0.5 million in legal settlement fees.
Other Expense. Total other expense increased by $2.3 million, or 84%, to $5.0 million for the six months ended June 30, 2026, compared to $2.7 million for the six months ended June 30, 2025. The increase was primarily due to a decrease of $0.9 million in gain on lease modification and an increase of $0.4 million in change in fair value of investments in equity security, and an increase of $0.8 million in interest expense.
Net Loss. Net loss was $2.0 million and $3.5 million for six months ended June 30, 2026 and June 30, 2025, respectively.
Liquidity and Capital Resources
Based on our losses to date, current liabilities and anticipated future net revenues, operating expenses, debt repayment obligations, and cash and cash equivalents of $2.8 million as of June 30, 2026, we do not have sufficient operating capital for our business without raising additional capital. We realized a net loss of $2.0 million for the six months ended June 30, 2026 and we may continue to incur net losses for the foreseeable future and until we can generate increased net revenues from Endari® sales. There is no assurance that we will be able to increase our Endari® sales or attain sustainable profitability, or that we will have sufficient capital resources to fund our operations until we are able to generate sufficient cash flow from operations or accomplish a strategic transaction.
Liquidity represents our ability to pay our liabilities when they become due, fund our business operations, meet our contractual obligations, including repayment of our existing indebtedness and the purchase of API under our supply arrangements with Telcon, and execute our business plan. Our primary sources of liquidity are our cash balances at the beginning of each period, sales of future receipts to third parties, proceeds from related-party loans and other financing activities. Our short-term and long-term cash requirements consist primarily of working capital requirements, general corporate needs, our contractual obligations to purchase API from Telcon and pay debt service under our outstanding notes payable.
As of June 30, 2026, we had outstanding $13.4 million principal amount of convertible promissory notes and $9.3 million principal amount of other notes payable reflected in our current liabilities. Our minimum lease payment obligations were $1.7 million, of which $0.4 million was payable within 12 months.
Our API supply agreement with Telcon provides for an annual API purchase target of $5 million and a target "profit" (i.e., gross margin) to Telcon of $2.5 million. To the extent these targets are not met, Telcon may be entitled to payment of the shortfall or to offset the shortfall against the Telcon convertible bond and proceeds thereof that are pledged as collateral to secure our obligations. With our consent, in April 2026, Telcon offset KRW 3.8 billion, or approximately $2.6 million, against the principal amount of the Company's Telcon convertible bond and the Company released KRW1,281 million, or approximately $870,000, in cash proceeds to Telcon in satisfaction of the target shortfall for the year ended December 31, 2025.
Due to uncertainties regarding our ability to meet our current and future operating and capital expenses, there is substantial doubt about our ability to continue as a going concern for 12 months from the date that our condensed consolidated financial statements are issued, as referred to in the "Risk Factors" section of our Annual Report and Note 2 of the Notes to Condensed Consolidated Financial Statements included herein.
Cash flows for the three months ended June 30, 2026 and June 30 2025
Net cash provided (used) in operating activities
Net cash provided in operating activities increased by $4.0 million, or 151%, to $1.3 million for the six months ended June 30, 2026 from net cash used in operating activities of $2.6 million for the six months ended June 30, 2025. This increase was primarily due to a decrease in net loss.
Net cash provided by investing activities
Net cash provided by investing activities decreased by $0.6 million, or 27%, to $1.6 million for the six months ended June 30, 2026 compared to $2.2 million for the six months ended June 30, 2025. The decrease was primarily due to an increase of $1 million in purchase of equity security, partially offset by an increase of $0.4 million in proceeds from sales of convertible bond.
Net cash used in financing activities
Net cash used in financing activities increased by $2.2 million to $2.2 million for the six months ended June 30, 2026 from $0.1 million for the six months ended June 30, 2025. The increase was mainly due to a reduction of $2.1 million in proceeds from note payable issued.
Off-Balance-Sheet Arrangements
We have no off-balance sheet arrangements.
Critical Accounting Estimates
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 ("GAAP"). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of certain assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including but not limited to those relating to revenue recognition on product sales, the variables used to calculate the valuation of investment in convertible bond, conversion feature, stock options and warrants. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the present 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.
Refer to "Critical Accounting Estimates and Accounting Policies" in Part II, Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations" of the Annual Report for additional information. There have been no material changes in any of our critical accounting estimates during the six months ended June 30, 2026.