EX-99.2 3 ea021004502ex99-2_aditxtinc.htm UNAUDITED FINANCIAL STATEMENTS OF EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES AS OF AND FOR THE THREE MONTHS ENDED MARCH 31, 2024 AND 2023

Exhibit 99.2

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

(Unaudited)

(In thousands, except par value and share data)

 

   As of 
   March 31,
2024
   December 31,
2023
 
Assets        
Current assets:        
Cash and cash equivalents  $-   $- 
Restricted cash   689    580 
Trade accounts receivable, net   4,306    5,738 
Inventories   1,306    1,697 
Prepaid and other current assets   622    1,195 
Total current assets   6,923    9,210 
           
Property and equipment, net   1,200    1,203 
Operating lease right-of-use assets   59    106 
Other noncurrent assets   35    35 
Total assets  $8,217   $10,554 
Liabilities, convertible and redeemable preferred stock and stockholders’ deficit          
Current liabilities:          
Accounts payable  $16,294   $17,020 
Notes - carried at fair value (Note 4)   13,252    14,731 
Convertible notes - Adjuvant (Note 4)   29,101    28,537 
Accrued expenses   4,575    4,227 
Accrued compensation   3,261    2,609 
Operating lease liabilities-current   55    97 
Derivative liabilities   4,310    1,926 
Other current liabilities   3,391    3,316 
Total current liabilities   74,239    72,463 
Operating lease liabilities- noncurrent   4    8 
Total liabilities   74,243    72,471 
Commitments and contingencies (Note 7)   -    - 
Convertible and redeemable preferred stock, $0.0001 par value, Senior to common stock          
Series E-1, and F-1 convertible preferred stock, 2,300 and 95,000 shares authorized; 1,921 and 1,874 shares of E-1 issued and outstanding at March 31, 2024 and December 31, 2023, respectively; 22,280 shares of F-1 issued and outstanding at each of March 31, 2024 and December 31, 2023   4,640    4,593 
Stockholders’ deficit:          
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding at March 31, 2024 and December 31, 2023   -    - 
Common Stock, $0.0001 par value; 3,000,000,000 shares authorized; 48,710,395 and 20,007,799 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively   5    2 
Additional paid-in capital   823,409    823,036 
Accumulated other comprehensive loss   (525)   (849)
Accumulated deficit   (893,555)   (888,699)
Total stockholders’ deficit   (70,666)   (66,510)
Total liabilities, convertible and redeemable preferred stock and stockholders’ deficit  $8,217   $10,554 

 

See accompanying notes to the condensed consolidated financial statements (unaudited).

 

F-1

 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(Unaudited)

(In thousands, except share and per share data)

 

   Three Months Ended March 31, 
   2024   2023 
Product sales, net  $3,603   $5,809 
           
Operating Expenses:          
Cost of goods sold   684    1,376 
Research and development   594    540 
Selling and marketing   2,345    3,854 
General and administrative   2,824    3,618 
Total operating expenses   6,447    9,388 
Loss from operations   (2,844)   (3,579)
Other income (expense):          
Interest income   4    18 
Other expense, net   (616)   (318)
Loss on issuance of financial instruments (Note 8)   (3,275)   (84)
Gain on debt extinguishment   1,120    - 
Change in fair value of financial instruments (Note 6)   802    1,612 
Total other income (expense), net   (1,965)   1,228 
Loss before income tax   (4,809)   (2,351)
Income tax expense   -    (3)
Net loss   (4,809)   (2,354)
Convertible preferred stock deemed dividends   (47)   - 
Net loss attributable to common stockholders  $(4,856)  $(2,354)
Net loss per share attributable to common stockholders (basic and diluted):  $(0.16)  $(1.85)
Weighted-average shares used to compute net loss per share attributable to common shareholders
(basic and diluted):
   31,194,393    1,271,524 

 

See accompanying notes to condensed consolidated financial statements (unaudited).

 

F-2

 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE OPERATIONS

 

(Unaudited)

(In thousands, except share and per share data)

 

   Three Months Ended March 31, 
   2024   2023 
Net loss  $(4,809)  $(2,354)
Other comprehensive income:          
Change in fair value of financial instruments attributed to credit risk change (Note 4)   324    15,460 
Comprehensive income (loss)  $(4,485)  $13,106 

 

See accompanying notes to condensed consolidated financial statements (unaudited).

 

F-3

 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE AND REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT

 

(Unaudited)

(In thousands, except share data)

 

   Series E-1
Convertible
and
Redeemable
Preferred
Stock
   Series F-1
Convertible
and
Redeemable
Preferred
Stock
   Common Stock   Additional
Paid-in
   Accumulated
Other
Comprehensive
   Accumulated   Total
Stockholders’
 
   Shares   Amount   Shares   Amount   Shares   Amount   Capital   Income (Loss)   Deficit   Deficit 
Balance as of January 1, 2024   1,874   $1,874    22,280   $2,719    20,007,799   $           2   $823,036   $(849)  $(888,699)  $(66,510)
Issuance of common stock upon exercise of warrants   -    -    -    -    246,153    -    15    -    -    15 
Issuance of common stock upon noncash exercise of purchase rights   -    -    -    -    17,725,000    2    87    -    -    89 
Issuance of common stock upon
conversion of notes
   -    -    -    -    10,731,443    1    34    -    -    35 
Stock-based compensation   -    -    -    -    -    -    237    -    -    237 
Change in fair value of financial instruments attributed to credit risk change (Note 4)   -    -    -    -    -    -    -    324    -    324 
Series E-1 shares dividends   47    47    -    -    -    -    -    -    (47)   (47)
Net loss   -    -    -    -    -    -    -    -    (4,809)   (4,809)
Balance as of March 31, 2024   1,921   $1,921    22,280   $2,719    48,710,395   $5   $823,409   $(525)  $(893,555)  $(70,666)

 

   Common Stock   Additional
Paid-in
   Accumulated
Other
Comprehensive
   Accumulated   Total
Stockholders’
 
   Shares   Amount   Capital   Income   Deficit   Deficit 
Balance as of January 1, 2023   984,786   $       -   $817,367   $49,527   $(938,694)  $(71,800)
Issuance of common stock upon cash exercise of warrants   24,200    -    67    -    -    67 
Issuance of common stock upon noncash exercise of Purchase Rights (Note 4)   718,704    -    180    -    -    180 
Issuance of SSNs (Note 4)   -    -    1,629    -    -    1,629 
Change in fair value of financial instruments attributed to credit risk change (Note 4)   -    -    -    15,460    -    15,460 
Stock-based compensation   -    -    417    -    -    417 
Net loss   -    -    -    -    (2,354)   (2,354)
Balance as of March 31, 2023   1,727,690   $-   $819,660   $64,987   $(941,048)  $(56,401)

 

See accompanying notes to condensed consolidated financial statements (unaudited).

 

F-4

 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

(Unaudited)

(In thousands)

 

   Three months ended March 31, 
   2024   2023 
Cash flows from operating activities:        
Net loss  $(4,809)  $(2,354)
Adjustments to reconcile net loss to net cash, cash equivalents and restricted cash provided by (used in) operating activities:          
Loss on issuance of financial instruments   3,275    84 
Change in fair value of financial instruments   (802)   (1,612)
Gain on debt extinguishment   (1,120)   - 
Stock-based compensation   237    417 
Depreciation   12    245 
Noncash interest expense   564    565 
Noncash right-of-use amortization   47    504 
Net loss on disposal of property and equipment   5    - 
Changes in operating assets and liabilities:          
Trade accounts receivable   1,432    (6,278)
Inventories   391    (99)
Prepaid and other assets   573    1,518 
Accounts payable   (726)   3,813 
Accrued expenses and other liabilities   438    (352)
Accrued compensation   652    (800)
Operating lease liabilities   (46)   (591)
Net cash and restricted cash provided by (used in) operating activities   123    (4,940)
Cash flows from investing activities:          
Purchases of property and equipment   (14)   (3)
Net cash and restricted cash used in investing activities   (14)   (3)
Cash flows from financing activities:          
Proceeds from issuance of common stock - exercise of warrants   -    61 
Borrowings under term notes   -    1,640 
Net cash and restricted cash provided by financing activities   -    1,701 
Net change in cash, cash equivalents and restricted cash   109    (3,242)
Cash, cash equivalents and restricted cash, beginning of period   580    4,776 
Cash, cash equivalents and restricted cash, end of period  $689   $1,534 
Supplemental disclosure of noncash investing and financing activities:          
Issuance of common stock upon exercise of purchase rights   89    180 
Purchases of property and equipment included in accounts payable and accrued expenses   78    140 
Series E-1 shares deemed dividends   47    - 
Issuance of common stock upon conversion of notes   35    - 
Issuance of common stock upon exercise of warrants   15    - 
Financing costs included in accounts payable and accrued expenses   -    125 

 

See accompanying notes to condensed consolidated financial statements (unaudited).

 

F-5

 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

1. Description of Business and Basis of Presentation

 

Description of Business

 

Evofem is a San Diego-based, commercial-stage biopharmaceutical company committed to commercializing innovative products to address unmet needs in women’s sexual and reproductive health.

 

The Company’s first commercial product, Phexxi® (lactic acid, citric acid, and potassium bitartrate) vaginal gel (Phexxi), was approved by the U.S. Food and Drug Administration (FDA) on May 22, 2020, and is the first and only FDA-approved, hormone-free, woman-controlled, on-demand prescription contraceptive gel for women. The Company commercially launched Phexxi in September 2020. Phexxi net product sales were $16.8 million in 2022 and increased to $18.2 million in 2023.

 

On December 11, 2023, the Company entered into an Agreement and Plan of Merger, as amended (the Merger Agreement) with Aditxt, Inc., a Delaware corporation (Aditxt) and Adifem, Inc. (f/k/a Adicure, Inc.), a Delaware corporation, and a wholly-owned Subsidiary of Aditxt (Merger Sub), pursuant to which, and on the terms and subject to the conditions thereof, the Merger Sub was expected to merge with and into the Company, with the Company surviving as a wholly owned subsidiary of Aditxt (the Merger). As discussed in Note 10 – Subsequent Events, on April 26, 2024, the Company delivered a termination notice to Aditxt notifying it that the Company was exercising its right to terminate the Merger Agreement in accordance with Section 8.1(f) of the Merger Agreement. As further described (and defined) in Note 10 – Subsequent Events, on May 2, 2024, the Company entered into the Reinstatement and Fourth Amendment to the Merger Agreement with Aditxt in order to reinstate and amend the Merger Agreement.

 

Basis of Presentation and Principles of Consolidation

 

The Company prepared the unaudited interim condensed consolidated financial statements included in this Quarterly Report in accordance with accounting principles generally accepted (GAAP) in the United States for interim financial information and the rules and regulations of the Securities and Exchange Commission (SEC) related to quarterly reports on Form 10-Q.

 

The Company’s financial statements are presented on a consolidated basis, which include the accounts of the Company and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements do not include all information and disclosures required by GAAP for annual audited financial statements and should be read in conjunction with the Company’s condensed consolidated financial statements and notes thereto for the year ended December 31, 2023 included in its Annual Report on Form 10-K as filed with the SEC on March 27, 2024 (the 2023 Audited Financial Statements).

 

The unaudited interim condensed consolidated financial statements included in this report have been prepared on the same basis as the Company’s audited consolidated financial statements and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of the financial position, results of operations, cash flows, and statements of convertible and redeemable preferred stock and stockholders’ deficit for the periods presented. The results for the three months ended March 31, 2024 are not necessarily indicative of the results expected for the full year. The condensed consolidated balance sheet as of December 31, 2023 was derived from the 2023 Audited Financial Statements.

 

F-6

 

 

Risks, Uncertainties and Going Concern

 

Any disruptions in the commercialization of Phexxi and/or its supply chain could have a material adverse effect on the Company’s business, results of operations and financial condition.

 

The condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities, in the normal course of business, and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty.

 

The Company’s principal operations are related to the commercialization of Phexxi. Additional activities have included raising capital, identifying alternative manufacturing to lower the cost of goods sold (COGS), seeking ex-U.S. licensing partners and product in-licensing/acquisition opportunities to add non-dilutive capital to the balance sheet, and establishing and maintaining a corporate infrastructure to support a commercial product. The Company has incurred operating losses and negative cash flows from operating activities since inception. As of March 31, 2024, the Company a working capital deficit of $67.3 million and an accumulated deficit of $893.6 million.

 

Since October 3, 2022, the Company’s common stock has traded on the OTC Venture Market (the OTCQB) of the OTC Markets Group, Inc., a centralized electronic quotation service for over-the-counter securities, under the symbol “EVFM.” The OTCQB imposes, among other requirements, a minimum $0.01 per share bid price requirement (the Bid Price Requirement) for continued inclusion on the OTCQB. The closing bid price for the Company’s common stock must remain at or above $0.01 per share to comply with the Bid Price Requirement for continued listing. As of May 10, 2024, the closing price was $0.0136.

 

Management’s plans to meet its cash flow needs in the next 12 months include generating recurring product revenue, restructuring its current payables, and obtaining additional funding through means such as the issuance of its capital stock, non-dilutive financings, or through collaborations or partnerships with other companies, including license agreements for Phexxi in the U.S. or foreign markets, or other potential business combinations.

 

The Company anticipates it will continue to incur net losses for the foreseeable future. According to management estimates, liquidity resources as of March 31, 2024 were not sufficient to maintain the Company’s cash flow needs for the twelve months from the date of issuance of these condensed consolidated financial statements.

 

If the Company is not able to obtain the required funding through a significant increase in revenue, equity or debt financings, license agreements for Phexxi in the U.S. or foreign markets, or other means, or is unable to obtain funding on terms favorable to the Company, or if there is another event of default affecting the notes payable, there will be a material adverse effect on commercialization operations and the Company’s ability to execute its strategic development plan for future growth. If the Company cannot successfully raise additional funding and implement its strategic development plan, the Company may be forced to make further reductions in spending, including spending in connection with its commercialization activities, extend payment terms with suppliers, liquidate assets where possible at a potentially lower amount than as recorded in the condensed consolidated financial statements, suspend or curtail planned operations, or cease operations entirely. Any of these could materially and adversely affect the Company’s liquidity, financial condition and business prospects, and the Company would not be able to continue as a going concern. The Company has concluded that these circumstances and the uncertainties associated with the Company’s ability to obtain additional equity or debt financing on terms that are favorable to the Company, or at all, and otherwise succeed in its future operations raise substantial doubt about the Company’s ability to continue as a going concern.

 

F-7

 

 

2. Summary of Significant Accounting Policies

 

Use of Estimates

 

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and the notes thereto.

 

Significant estimates affecting amounts reported or disclosed in the condensed consolidated financial statements include, but are not limited to: the assumptions used in measuring the revenue gross-to-net variable consideration items; the trade accounts receivable credit loss reserve estimate; the assumptions used in estimating the fair value of convertible notes, preferred stock, warrants and purchase rights issued; the assumptions used in the valuation of inventory; the useful lives of property and equipment; the recoverability of long-lived assets; and the valuation of deferred tax assets. These assumptions are more fully described in Note 3 – Revenue, Note 4 – Debt, Note 6 - Fair Value of Financial Instruments, Note 7 - Commitments and Contingencies, and Note 9 - Stock-based Compensation. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances and adjusts when facts and circumstances dictate. The estimates are the basis for making judgments about the carrying values of assets, liabilities and recorded expenses that are not readily apparent from other sources. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.

 

Segment Reporting

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker, the Chief Executive Officer of the Company, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment.

 

Concentrations of Credit Risk

 

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and restricted cash. Deposits in the Company’s checking, time deposit and investment accounts are maintained in federally insured financial institutions and are subject to federally insured limits or limits set by Securities Investor Protection Corporation. The Company invests in funds through a major U.S. bank and is exposed to credit risk in the event of default to the extent of amounts recorded on the condensed consolidated balance sheets.

 

The Company has not experienced any losses in such accounts and believes it is not exposed to significant concentrations of credit risk on its cash, cash equivalents and restricted cash balances on amounts in excess of federally insured limits due to the financial position of the depository institutions in which these deposits are held.

 

The Company is also subject to credit risk related to its trade accounts receivable from product sales. Its customers are located in the U.S. and consist of wholesale distributors, retail pharmacies, and mail-order specialty pharmacies. The Company extends credit to its customers in the normal course of business after evaluating their overall financial condition and evaluates the collectability of its accounts receivable by periodically reviewing the age of the receivables, the financial condition of its customers, and its past collection experience. Historically, the Company has not experienced any credit losses. As of March 31, 2024, based on the evaluation of these factors the Company did not record an allowance for doubtful accounts.

 

Phexxi is distributed primarily through three major distributors and mail-order pharmacies, who receive service fees calculated as a percentage of the gross sales, and a fee-per-unit shipped, respectively. These entities are not obligated to purchase any set number of units. They distribute Phexxi on demand as orders are received.

 

For the three months ended March 31, 2024, and 2023, the Company’s three largest customers combined made up approximately 82% and 86% of its gross product sales, respectively. As of March 31, 2024 and December 31, 2023, the Company’s three largest customers combined made up 89% and 87%, respectively, of its trade accounts receivable balance.

 

F-8

 

 

Significant Accounting Policies

 

There have been no changes to the significant accounting policies that were described in Note 2 – Summary of Significant Accounting Policies of the 2023 Audited Financial Statements in the Company’s Annual Report.

 

Cash, Cash Equivalents and Restricted Cash

 

Cash and cash equivalents consist of readily available cash in checking accounts and money market funds. Restricted cash consists of cash held in monthly time deposit accounts and letters of credit as described in Note 7- Commitments and Contingencies. During the quarter ended March 31, 2023, the letters of credit of $0.3 million for its fleet leases were released. Additionally, the remaining funds of the $25.0 million received from the issuance of Adjuvant Notes (as defined below) in the fourth quarter of 2020 are classified as restricted cash since the Company is contractually obligated to use these funds for specific purposes. Upon receipt of a notice of default from its landlord on March 20, 2023, for failing to pay March 2023 rent timely resulting in a breach under the office lease agreement, the Company’s letter of credit in the amount of $0.8 million, in restricted cash, was recovered by the landlord.

 

The following table provides a reconciliation of cash, cash equivalents and restricted cash, reported within the condensed consolidated statements of cash flows (in thousands):

  

   Three months ended March 31, 
   2024   2023 
Cash and cash equivalents  $-   $639 
Restricted cash   689    895 
Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows  $689   $1,534 

 

Net Loss Per Share

 

Basic net loss per share attributable to common stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. The net loss available to common stockholders is adjusted for amounts in accumulated deficit related to the deemed dividends triggered for certain financial instruments. Such adjustment was immaterial and zero in the three months ended March 31, 2024 and 2023, respectively. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for the three months ended March 31, 2024 and 2023. Potentially dilutive securities excluded from the calculation of diluted net loss per share are summarized in the table below. Common shares were calculated for the convertible preferred stock and the convertible debt using the if-converted method.

 

   Three months ended March 31, 
   2024   2023 
Options to purchase common stock   3,747    4,843 
Warrants to purchase common stock   20,807,543    3,180,282 
Purchase rights to purchase common stock   1,530,645,242    14,238,827 
Convertible debt   2,430,230,049    18,042,988 
Series E-1 and F-1 preferred stock   1,531,629,677    - 
Total(1)   5,513,316,258    35,466,940 

 

(1) The potentially dilutive securities in the table above include all potentially dilutive securities that are not included in the diluted EPS as per U.S. GAAP, whereas the total common stock reserved for future issuance in Note 8 – Stockholders’ Deficit includes the shares that must legally be reserved based on the applicable instruments’ agreements.

 

Recently Adopted Accounting Pronouncements

 

No significant new standards have been adopted during the three months ended March 31, 2024.

 

Recently Issued Accounting Pronouncements — Not Yet Adopted

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standards setting bodies that are adopted as of the specified effective date.

 

F-9

 

 

In November 2023, the FASB issued ASU No. 2023-07, Improvements to Reportable Segment Disclosures, designed to improve financial reporting by requiring disclosure of incremental segment information to enable investors to develop more decision-useful financial analyses. ASU No. 2023-07 will be effective for the Company beginning with the annual filing for the period ended December 31, 2024 and will require retroactive application to comparison periods presented. For Companies that have only one reportable segment (such as the Company), all the requirements of ASU No. 2023-07 will be required to be disclosed regarding the one reportable segment. The Company is still evaluating the impact of ASU No. 2023-07 on the consolidated financial statements.

 

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes: Improvements to Income Tax Disclosures addressing income tax disclosures, requiring entities to annually disclose specific categories in the rate reconciliation and provide additional information for certain reconciling items and categories. ASU No. 2023-09 will be effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. The Company will adopt ASU No. 2023-09 by adding the required disclosures for the December 31, 2024 Annual Report.

 

The Company does not believe the impact of any other recently issued standards and any issued but not yet effective standards will have a material impact on its condensed consolidated financial statements upon adoption.

 

3. Revenue

 

The Company recognizes revenue from the sale of Phexxi in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

 

In accordance with ASC 606, the Company recognizes revenue when its performance obligation is satisfied by transferring control of the product to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are located in the U.S. and consist of wholesale distributors, retail pharmacies, and mail-order specialty pharmacies. Payment terms typically range from 31 to 66 days, include prompt pay discounts, and vary by customer. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the condensed consolidated balance sheets, net of various allowances as described in the Trade Accounts Receivable policy in Note 2 – Summary of Significant Accounting Policies to the 2023 Audited Financial Statements.

 

The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when the performance obligation is satisfied. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue.

  

Phexxi is sold to customers at the wholesale acquisition cost (WAC) or, in some cases, at a discount to WAC. However, the Company records product revenue net of reserves for applicable variable consideration. These types of variable consideration reduce revenue and include the following:

 

  Distribution services fees
     
  Prompt pay and other discounts
     
  Product returns
     
  Chargebacks
     
  Rebates
     
  Patient support programs, including our co-pay programs

 

F-10

 

 

An estimate for variable consideration is made with each sale and is recorded in conjunction with the revenue being recognized. To calculate the variable consideration, the Company uses the expected value method and the estimated amounts are recorded as a reduction to accounts receivable or as a current liability based on the nature of the allowance and the terms of the related arrangements. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed and adjustments are made if necessary. Any adjustments made to these provisions would also affect net product revenue and earnings.

 

In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance, such as Medicaid, versus private commercial insurance. To determine these estimates, the Company relies on historical sales data showing the amount of various end-user consumer types, inventory reports from the wholesale distributors and mail-order specialty pharmacies, and other relevant data reports.

 

The specific considerations that the Company uses in estimating these amounts related to variable consideration are as follows:

 

Distribution services fees – The Company pays distribution service fees to its wholesale distributors and mail-order specialty pharmacies. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company considers these fees to be separate from the customer’s purchase of the product and, therefore, they are recorded in other current liabilities on the condensed consolidated balance sheets.

 

Prompt pay and other discounts – The Company incentivizes its customers to pay their invoices on time through prompt pay discounts. These discounts are an industry standard practice, and the Company offers a prompt pay discount to each wholesale distributor and retail pharmacy customer. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are typically taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the purchase amount. Prompt pay discount estimates are recorded as contra trade accounts receivable on the condensed consolidated balance sheets.

 

The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recognized.

 

Chargebacks – Certain government entities and covered entities (e.g., Veterans Administration, 340B covered entities) are able to purchase Phexxi at a price discounted below WAC. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount of each chargeback channel based on the expected number of claims in each channel and related chargeback that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the condensed consolidated balance sheets.

 

Rebates – The Company is subject to mandatory discount obligations under the Medicaid and Tricare programs. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates for Medicaid and Tricare are typically invoiced in arrears. The Company estimates the amount of rebates based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities on the condensed consolidated balance sheets.

 

F-11

 

 

Patient support programs – The Company offers a voluntary co-pay program to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of financial assistance for these programs based on the expected number of claims and related cost associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Patient support programs estimates are recorded as other current liabilities on the condensed consolidated balance sheets.

 

Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. Phexxi was commercially launched in September 2020 with a 30-month shelf life. The shelf life increased to 48 months in June 2022. The Company uses historical sales and return data to estimate future product returns. Product return estimates are recorded as other current liabilities on the condensed consolidated balance sheets.

 

The variable considerations discussed above were recorded in the condensed consolidated balance sheets and consisted of $0.2 million and $0.3 million in contra trade accounts receivable as of March 31, 2024 and December 31, 2023, respectively and $3.2 million in other current liabilities as of both March 31, 2024 and December 31, 2023.

 

4. Debt

 

Convertible Notes

 

Baker Bros. Notes (temporarily owned by Aditxt from December 11, 2023 through February 26, 2024)

 

On April 23, 2020, the Company entered into a Securities Purchase and Security Agreement (the Baker Bros. Purchase Agreement) with certain affiliates of Baker Bros. Advisors LP, as purchasers (the Baker Purchasers), and Baker Bros. Advisors LP, as designated agent, pursuant to which the Company agreed to issue and sell to the Baker Purchasers (i) convertible senior secured promissory notes (the Baker Notes) in an aggregate principal amount of up to $25.0 million and (ii) warrants to purchase shares of common stock (the Baker Warrants) in a private placement, which closed in two closings (April 24, 2020, the Baker Initial Closing, and June 9, 2020, the Baker Second Closing) As a result of the two closings, the Company issued and sold Baker Notes with an aggregate principal amount of $25.0 million and Baker Warrants exercisable for 2,731 shares of common stock. Upon the completion of the underwritten public offering in June 2020, the exercise price of the Baker Warrants was $4,575 per share. The Baker Warrants have a five-year term with a cashless exercise provision and are immediately exercisable at any time from their respective issuance date.

 

The Baker Notes had a five-year term, with no pre-payment ability during the first three years. Interest on the unpaid principal balance of the Baker Notes (the Baker Outstanding Balance) accrues at 10.0% per annum with interest accrued during the first year from the two respective closing dates recognized as payment-in-kind. The effective interest rate for the period was 10.0%. Accrued interest beyond the first year of the respective closing dates is to be paid in arrears on a quarterly basis in cash or recognized as payment-in-kind, at the direction of the Baker Purchasers. As discussed below, with the amendment to the Baker Bros. Purchase Agreement, interest payments were paid in-kind. Interest pertaining to the Baker Notes for the three months ended March 31, 2024 and 2023 was approximately $2.5 million and $1.4 million, respectively, which was added to the outstanding principal balance. The Company accounts for the Baker Notes under the fair value method as described below and, therefore, the interest associated with the Baker Notes is included in the fair value determination.

 

The Baker Notes were callable by the Company on 10 days’ written notice beginning on the third anniversary of the initial closing date of April 24, 2020. The call price equals 100% of the Baker Outstanding Balance plus accrued and unpaid interest if the Company’s common stock as measured using a 30-day volume weighted average price (VWAP) was greater than the benchmark price of $9,356.25 as stated in the Baker Bros. Purchase Agreement, or 110% of the Baker Outstanding Balance plus accrued and unpaid interest if the VWAP was less than such benchmark price. The Baker Purchasers also had the option to require the Company to repurchase all or any portion of the Baker Notes in cash upon the occurrence of certain events. In a repurchase event, as defined in the Baker Bros. Purchase Agreement, the repurchase price will equal 110% of the Baker Outstanding Balance plus accrued and unpaid interest. In the event of default or the Company’s change of control, the repurchase price would equal to the sum of (x) three times of the Baker Outstanding Balance plus (y) the aggregate value of future interest that would have accrued. The Baker Notes were convertible at any time at the option of the Baker Purchasers at the conversion price of $4,575 per share prior to the First and Second Baker Amendments (as defined below).

 

F-12

 

 

On November 20, 2021, the Company entered into the first amendment to the Baker Bros. Purchase Agreement (the First Baker Amendment), in which each Baker Purchaser had the right to convert all or any portion of the Baker Notes into common stock at a conversion price equal to the lesser of (a) $4,575 and (b) 115% of the lowest price per share of common stock (or, as applicable with respect to any equity securities convertible into common stock, 115% of the applicable conversion price) sold in one or more equity financings until the Company has met a qualified financing threshold defined as one or more equity financings resulting in aggregate gross proceeds to the Company of at least $50 million (the Financing Threshold).

 

The First Baker Amendment also extended, effective upon the Company’s achievement of the Financing Threshold, the affirmative covenant to achieve $100.0 million in cumulative net sales of Phexxi by June 30, 2022 to June 30, 2023. Additionally per the First Baker Amendment, if the Company were to issue warrants to purchase capital stock of the Company (or other similar consideration) in any equity financing that closed on or prior to the date on which the Company met the Financing Threshold, the Company was required to issue to the Baker Purchasers an equivalent coverage of warrants (or other similar consideration) on the same terms as if the Baker Purchasers had participated in the financing in an amount equal to the then outstanding principal of Baker Notes held by the Baker Purchasers. In satisfaction of this requirement and in connection with the closing of the May 2022 Public Offering, the Company issued warrants to purchase 582,886 shares of the Company’s common stock at an exercise price of $93.75 per share to the Baker Purchasers (the June 2022 Baker Warrants). As required by the terms of the First Baker Amendment, the June 2022 Baker Warrants have substantially the same terms as the warrants issued in the May 2022 Public Offering. Refer to Note 8 – Stockholders’ Deficit for further information. The exercise price of the initial Baker Warrants and the June 2022 Baker Warrants was reset multiple times as a result of various Notes issuances in accordance with the agreement and the exercise price as of March 31, 2024 was $0.0158 per share. Subsequent to March 31, 2024, the conversion price adjusted to $0.0154, as discussed in Note 10 – Subsequent Events.

 

On March 21, 2022, the Company entered into the second amendment to the Baker Bros. Purchase Agreement (the Second Baker Amendment), which granted each Baker Purchaser the right to convert all or any portion of the Baker Notes into common stock at a conversion price equal to the lesser of (a) $725.81 or (b) 100% of the lowest price per share of common stock (or as applicable with respect to any equity securities convertible into common stock, 100% of the applicable conversion price) sold in any equity financing until the Company has (i) met the qualified financing threshold by June 30, 2022, defined as a single underwritten financing resulting in aggregate gross proceeds to the Company of at least $20 million (Qualified Financing Threshold) and (ii) the disclosure of top-line results from the EVOGUARD clinical trial (the Clinical Trial Milestone) by October 31, 2022. The Second Baker Amendment also provided that the exercise price of the Baker Warrants will equal the conversion price of the Baker Notes. The Company met the Qualified Financing Threshold upon the closing of the May 2022 Public Offering, and as of September 30, 2022, the conversion price and exercise price of the Baker Warrants was reset to $93.75. The Company achieved the Clinical Trial Milestone in October 2022. Also, with the achievement of the Qualified Financing Threshold and the Clinical Trial Milestone, the affirmative covenant to achieve $100.0 million in cumulative net sales of Phexxi was extended to June 30, 2023, which was subsequently waived via the Baker Fourth Amendment as discussed below.

 

On September 15, 2022, the Company entered into the third amendment to the Baker Bros. Purchase Agreement (the Third Baker Amendment), pursuant to which the conversion price was amended to $26.25, subject to adjustment for certain dilutive Company equity issuance adjustments for a two-year period; an interest make-whole payment due in certain circumstances was removed; and certain change of control and liquidation payment amounts were reduced from three times the outstanding amounts of the Baker Notes to two times the outstanding amounts. In addition, the Third Baker Amendment provided that the Company may make future interest payments to the Baker Purchasers in kind or in cash, at the Company’s option. On the same day, the Company also entered into a Secured Creditor Forbearance Agreement with the Baker Purchasers (Baker Forbearance Agreement), according to which the Baker Purchasers agreed to forebear the defaults that existed at that time.

 

On December 19, 2022, the Company entered into the First Amendment to the Forbearance Agreement (the Amendment) effective as of December 15, 2022 to amend certain provisions of the Forbearance Agreement dated September 15, 2022. The Amendment revised the Forbearance Agreement to (i) amend the Fifth Recital Clause to clarify that the Purchasers consent to any additional indebtedness pari passu, but not senior to that of the Purchasers, in an amount not to exceed $5.0 million, and (ii) strike and entirely replace Section 4 to clarify the terms of the Purchasers’ consent to Interim Financing (as defined therein). No other revisions were made to the Forbearance Agreement.

 

F-13

 

 

On March 7, 2023, Baker Bros. Advisors, LP (the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the Notice of Default) relating to the Baker Bros. Purchase Agreement. The Notice of Default claimed that the Company failed to maintain the “Required Reserve Amount” as required by the Third Baker Amendment. The Designated Agent, at the direction of the Baker Purchasers, accelerated repayment of the outstanding balance payable. As a result, approximately $92.7 million, representing two times the sum of the outstanding balance and all accrued and unpaid interest thereon and all other amounts due under the Baker Bros. Purchase Agreement and other documents, was due and payable within three business days of receipt of the Notice of Default. In addition, the Company did not meet the $100.0 million cumulative net sales threshold by June 30, 2023 and as such was in default as of that date. As discussed below, all existing defaults were cured upon the signing of the Fourth Baker Amendment.

 

On September 8, 2023, the Company entered into the Fourth Amendment to the Baker Bros. Purchase Agreement (the Fourth Baker Amendment) with the Baker Purchasers. The Fourth Amendment amends certain provisions within the Baker Bros. Purchase Agreement including:

 

  (i) the rescission of the Notice of Default delivered to the Company on March 7, 2023 and waiving the Events of Default named therein;
     
  (ii) the waiver of any and all other Events of Default existing as of the Fourth Amendment date;
     
  (iii) the removal of the conversion feature into shares of Company common stock, including the removal of any requirement to reserve shares of common stock for conversion of the Baker Notes as well as any registration rights related thereto;
     
  (iv) the clarification that for the sole purpose of enabling an ex-U.S. license agreement for such assets, any Patents, Trademarks or Copyrights acquired after the Effective Date shall be excluded from the definition of Collateral; and,
     
  (v) the removal of the requirement for the Company to obtain $100 million in cumulative net Phexxi sales in the specified timeframe.

 

The outstanding balance of the Baker Notes will continue to accrue interest at 10% per annum and, in the event of a default in the agreement or a failure to pay the Repurchase Price (as defined below) on or before September 8, 2028 (the Maturity Date), the Baker Purchasers may collect on the full principal amount then outstanding.

 

The Company was required to make a $1.0 million upfront payment by October 1, 2023 (which payment was made in late September 2023) as well as quarterly cash payments based upon a percentage of the Company’s global net product revenue. The cash payments will be determined based upon the quarterly global net revenue of Phexxi such that if the global net revenue is less than or equal to $5.0 million, the Company will pay 3% of such global net revenues; if the global net revenue is over $5.0 million and less than or equal to $7.0 million, the Company will continue to pay 3% on net revenue up to $5.0 million and 4% on the net revenue over $5.0 million; and if the global net revenue is over $7.0 million, the Company will pay 3% on the net revenue up to $5.0 million, 4% on the net revenue over $5.0 million up to $7.0 million, and 5% on net revenue over $7.0 million. The cash payments were payable beginning in the fourth quarter of 2023. Regardless of the percentage paid, the quarterly cash payment amounts, along with the $1.0 million upfront payment, will be deducted from the Repurchase Price as Applicable Reductions.

 

The Fourth Amendment also granted the Company the ability to repurchase the principal amount and accrued and unpaid interest of the Baker Notes for up to a five-year period for the one-time Repurchase Price designated below:

 

Date of Notes’ Repurchase   Repurchase Price
On or prior to September 8, 2024   $14,000,000 (less Applicable Reductions)
September 9, 2024-September 8, 2025   $16,750,000 (less Applicable Reductions)
September 9, 2025-September 8, 2026   $19,500,000 (less Applicable Reductions)
September 9, 2026-September 8, 2027   $22,250,000 (less Applicable Reductions)
September 9, 2027-September 8, 2028   $25,000,000 (less Applicable Reductions)

 

F-14

 

 

The Company evaluated whether any of the Embedded Features required bifurcation as a separate component. The Company elected the fair value option (FVO) under ASC 825, Financial Instruments (ASC 825), as the Baker Notes are qualified financial instruments and are, in whole, classified as liabilities. Under the FVO, the Company recognized the debt instrument at fair value, inclusive of the Embedded Features with changes in fair value related to changes in the Company’s credit risk being recognized as a component of accumulated other comprehensive loss in the condensed consolidated balance sheets. All other changes in fair value were recognized in the condensed consolidated statements of operations.

 

Due to the execution of the Fourth Baker Amendment, the Company reviewed the Baker Notes in accordance with ASC 470, Debt (ASC 470). Because the Baker Notes were recorded under the FVO, the Fourth Amendment was outside the scope of ASC 470-60 and as such did not qualify as a troubled debt restructuring (TDR). The Baker Notes were evaluated in accordance with ASC 470 and were determined to have failed certain qualitative factors to qualify as a modification and, therefore, were accounted for as an extinguishment. The Company removed the fair value of the old Baker Notes of $15.6 million and the related accumulated other comprehensive income of $73.2 million as of the date of extinguishment and recorded the fair value of the new Baker Notes, as measured on the date of the Baker Fourth Amendment as $12.5 million, and recognized a gain of approximately $75.3 million within the condensed consolidated statements of operations, in the gain (loss) on issuance of financial instruments line item, upon extinguishment in the year ended December 31, 2023. The gain included recognizing $73.2 million that had previously been a component of other comprehensive income as part of the prior quarterly revaluations using the valuation methods discussed in Note 6 – Fair Value of Financial Instruments.

 

As part of the consideration for the Merger, on December 11, 2023, the Baker Purchasers signed an agreement to assign the Baker Notes to Aditxt (the December Assignment Agreement). Upon this December Assignment Agreement, Aditxt assumed all terms under the Baker Notes, with Aditxt becoming the new senior secured debtholder of the Company, governed by the requirements under the Fourth Baker Amendment. The Baker Notes were re-assigned back to the Baker Purchasers on February 26, 2024 (the February Assignment Agreement).

 

Due to the execution of the February Assignment Agreement, the Company reviewed the Baker Notes in accordance with ASC 470. The Baker Notes, having been effectively terminated, were extinguished on February 26, 2024, resulting in removing the fair value of the old Baker Notes of $13.5 million. The newly re-assigned Baker Notes were subsequently recorded at fair value using the valuation methods discussed in Note 6 – Fair Value of Financial Instruments.

 

As of March 31, 2024, the Baker Notes are recorded at fair value in the condensed consolidated balance sheet as short-term convertible notes payable with a total fair value of $12.3 million, and the total outstanding balance including principal and accrued interest is $102.0 million.

 

Adjuvant Notes

 

On October 14, 2020, the Company entered into a Securities Purchase Agreement (the Adjuvant Purchase Agreement) with Adjuvant Global Health Technology Fund, L.P., and Adjuvant Global Health Technology Fund DE, L.P. (together, the Adjuvant Purchasers), pursuant to which the Company sold unsecured convertible promissory notes (the Adjuvant Notes) in aggregate principal amount of $25.0 million.

 

The Adjuvant Notes have a five-year term, and in connection with certain Company change of control transactions, the Adjuvant Notes may be prepaid at the option of the Company or will become payable on the date of the consummation of a change of control transaction at the option of the Adjuvant Purchasers. The Adjuvant Notes accrue interest at 7.5% per annum on a quarterly basis in arrears to the outstanding balance of the Adjuvant Notes and are recognized as payment-in-kind. The effective interest rate for the three months ended March 31, 2024 was 8.8%.

 

F-15

 

 

Interest expense for the Adjuvant Notes consist of the following, and is included in other expense, net on the condensed consolidated statements of operations for the three months ended March 31, 2024 and 2023 (in thousands):

 

   Three Months Ended March 31, 
   2024   2023 
Coupon interest  $536   $497 
Amortization of issuance costs   28    68 
Total  $564   $565 

 

The Adjuvant Notes are convertible, subject to customary 4.99% and 19.99% beneficial ownership limitations, into shares of the Company’s common stock, par value $0.0001 per share, at any time at the option of the Adjuvant Purchasers at a conversion price of $6,843.75 per share. In connection with certain Company change of control transactions, the Adjuvant Notes may be prepaid at the option of the Company or will become payable at the option of the Adjuvant Purchasers. To the extent not previously prepaid or converted, the Adjuvant Notes were originally automatically convertible into shares of the Company’s common stock at a conversion price of $6,843.75 per share immediately following the earliest of the time at which the (i) 30-day value-weighted average price of the Company’s common stock was $18,750 per share, or (ii) the Company achieved cumulative net sales of $100.0 million, provided such net sales were achieved prior to July 1, 2022.

 

On April 4, 2022, the Company entered into the first amendment to the Adjuvant Purchase Agreement (the Adjuvant Amendment). The Adjuvant Amendment extended the affirmative covenant to achieve $100.0 million in cumulative net sales of Phexxi by June 30, 2022 to June 30, 2023. The Adjuvant Amendment also provided for an adjustment to the conversion price of the Adjuvant Notes such that the conversion price (the Conversion Price) for these Notes, effective as of the May 2023 reverse stock split, will now be the lesser of (i) $678.49 and (ii) 100% of the lowest price per share of common stock (or with respect to securities convertible into common stock, 100% of the applicable conversion price) sold in any equity financing until the Company has met the Qualified Financing Threshold. Effective as of the Company’s achievement of the Qualified Financing Threshold, the automatic conversion provisions in the Agreement were further amended to provide that the Adjuvant Notes will automatically convert into shares of the Company’s common stock at the Conversion Price immediately following the earliest of the time at which the (i) 30-day value-weighted average price of the Company’s common stock is $18,750 per share, or (ii) the Company achieves cumulative net sales of Phexxi of $100.0 million, provided such net sales were achieved prior to July 1, 2023.

 

The Adjuvant Notes contain various customary affirmative and negative covenants agreed to by the Company. On September 12, 2022, the Company was in default of the Adjuvant Notes due to the default with the Baker Notes under the cross-default provision. On September 15, 2022, the Company entered into a Forbearance Agreement (the Adjuvant Forbearance Agreement) with the Adjuvant Purchasers, pursuant to which the Adjuvant Purchasers agreed to forbear from exercising any of their rights and remedies during the Forbearance Period as defined in therein, but solely with respect to the specified events of default provided under the Adjuvant Forbearance Agreement.

 

On September 15, 2022, the Company also entered into the second amendment to the Adjuvant Purchase Agreement (the Second Adjuvant Amendment), pursuant to which the conversion price per share was reduced to $26.25, subject to adjustment for certain dilutive Company equity issuance adjustments for a two-year period. In addition, the Company entered into an exchange agreement, pursuant to which the Adjuvant Purchasers agreed to exchange 10% of the outstanding amount of the Adjuvant Notes as of September 15, 2022 (or $2.9 million) for rights to receive 109,842 shares of common stock (the Adjuvant Purchase Rights). The number of shares for each Adjuvant Purchase Right is initially fixed, but is subject to certain customary adjustments, and, until the second anniversary of issuance, adjustments for certain dilutive Company equity issuances. Refer to Note 8 - Stockholders’ Deficit for discussion regarding additional issuances of purchase rights under this provision. The Adjuvant Purchase Rights expire on June 28, 2027 and do not have an exercise price per share and, therefore, will not result in cash proceeds to the Company. As of March 31, 2024, all Adjuvant Purchase Rights remain outstanding. The conversion price of the Adjuvant Notes was reset during the quarter and was $0.0158 as of March 31, 2024. Subsequent to March 31, 2024, the conversion price adjusted to $0.0154, as discussed in Note 10 – Subsequent Events.

 

F-16

 

 

The Adjuvant Notes are accounted for in accordance with authoritative guidance for convertible debt instruments and are classified as current liabilities in the condensed consolidated balance sheets. The aggregate proceeds of $25.0 million were initially classified as restricted cash for financial reporting purposes due to contractual stipulations that specify the types of expenses the money can be spent on and how it must be allocated. The conversion feature was required to be bifurcated as an embedded derivative because the Company did not have a sufficient number of shares reserved upon conversion as of March 31, 2023; however, the fair value of such feature was immaterial as of such date. As of June 30, 2023, the Company had a sufficient number of shares reserved and the conversion feature was reclassified to stockholders’ deficit in accordance with ASC 815, Derivatives and Hedging (ASC 815) at that time. See Note 6 - Fair Value of Financial Instruments for a description of the accounting treatment for the Adjuvant Purchase Rights.

 

The Company was in default of the Adjuvant Notes at September 30, 2023, due to the failure to meet the cumulative net sales requirement. However, Adjuvant forbore such default in October 2023 and therefore the Company is no longer in default.

 

As of March 31, 2024, the Adjuvant Notes are recorded in the condensed consolidated balance sheet as short-term convertible notes payable with a total balance of $29.1 million. The balance is comprised of $22.5 million in principal, net of unamortized debt issuance costs, and $6.6 million in accrued interest. As of December 31, 2023, the Adjuvant Notes were recorded in the condensed consolidated balance sheet as short-term convertible notes payable with a total balance of $28.5 million. The balance was comprised of $22.5 million in principal, net of unamortized debt issuance costs, and $6.1 million in accrued interest.

 

As of March 31, 2024, and assuming the current conversion price of $0.0158 per share, the Adjuvant Notes could be converted into 1,842,275,987 shares of common stock.

 

Term Notes

 

December 2022 and February, March, April, July, August, and September 2023 Notes (SSNs)

 

The Company entered into eight similar Securities Purchase Agreements (SPAs) between December 2022 and September 2023 with certain investors. Each of the agreements were materially similar. The variable details of each SPA, such as the principal amount of each note offering, net proceeds, and maturity date, are outlined in the table below. Pursuant to each SPA, the Company agreed to sell in a registered direct offering (i) unsecured 8.0% senior subordinated notes with the maturity dates and aggregate issue prices (ii) warrants to purchase the listed number of shares of the Company’s common stock, $0.0001 par value per share (including prefunded common stock Warrants as a part of the September 2023 SPA) (iii) Series D Preferred Stock (the Preferred Shares; December 2022 SPA only) (collectively, the Senior Subordinated Notes, or SSNs). The SSNs had net proceeds to the Company from and are convertible at the amounts listed below.

 

The SSNs interest rates are subject to increase to 12% upon an event of default and the Notes have no Company right to prepayment prior to maturity; however, the Company has the option to redeem the respective SSNs at a redemption premium of 32.5%. The Purchasers can also require the Company to redeem their notes at the respective premium rate tied to the occurrence of certain subsequent transactions, as well as require the Company to redeem the SSNs in the event of subsequent placements (as defined). Also, pursuant to the terms of the SPAs, Purchasers have certain rights to participate in subsequent issuances of the Company’s securities, subject to certain exceptions. Additionally, the conversion rate and warrant strike price are subject to adjustment upon the issuance of other securities (as defined) less than the stated conversion rate and strike price at issuance. The strike prices adjusted as discussed in the table below. Additionally, subsequent to March 31, 2024, the conversion price of the SSNs was adjusted to $0.0154 per share due to the price reset requirements in the SPA.

 

The Company evaluated the SSNs in accordance with ASC 480 and determined that the Notes were all liability instruments at issuance. The applicable Notes were then evaluated in accordance with the requirements of ASC 825 and the Company concluded that they were not precluded from electing the fair value option for the applicable Notes.

 

F-17

 

 

The Company also evaluated the Warrants in accordance with ASC 480 and determined that the Warrants issued before the Reverse Stock Split in May 2023 were required to be recorded as liabilities at fair value in the Company’s condensed consolidated balance sheets. The applicable SSNs were marked-to-market at each reporting date with changes in fair value recognized in the condensed consolidated statement of operations, unless the change is concluded to be related to changes in the Company’s credit rating, in which case the change was recognized as a component of accumulated other comprehensive income in the condensed consolidated balance sheets. As a result of the Reverse Stock Split, the Company had sufficient shares available for issuance to cover the potential exercises; therefore, the Warrants that were previously classified as liabilities were marked-to-market and reclassified to equity in May 2023. For the Warrants issued after the Reverse Stock Split, the Company determined they were required to be recorded in equity.

 

On December 21, 2023, warrants to purchase up to 9,972,074 shares of the Company’s common stock were exchanged for 613 shares of the Company’s series F-1 convertible and redeemable preferred stock (Series F-1 Shares, as defined below). The Series F-1 Shares, some of which were also issued based on the partial value of certain purchase rights, as described above, were immediately exchanged to Aditxt series A-1 preferred stock and 22,280 Series F-1 Shares were outstanding as of December 31, 2023 and held by Aditxt. The Series F-1 Shares were to be cancelled upon the consummation of the Merger. As discussed in Note 10 – Subsequent Events, on April 26, 2024, the Company terminated the Merger Agreement for non-performance under section 8.1(f) and without penalty.

 

Summary of SSNs and Warrants at Issuance (December 2022 to September 2023):

 

   Principal
At Issuance
   Net
Proceeds
Before
Issuance
costs
              Conversion Price 
Notes  (in Thousands)   (in Thousands)  

Common

Warrants

   Preferred Shares   Maturity
Date
  At
Issuance
   At
3/31/2023
   At
6/30/2023
   At
9/30/2023
   At
12/31/2023
   At
3/31/2024
 
December 2022 Notes  $2,308   $1,500    369,230    70 - Series D    12/21/2025  $6.25   $1.625   $0.8125   $0.0845   $0.0615   $0.0158 
February 2023 Notes(1)   1,385    900    653,538    -   2/17/2026  $2.50   $1.625   $0.8125   $0.0845   $0.0615   $0.0158 
March 2023 Notes   600    390    240,000    -   3/17/2026  $2.50   $1.625   $0.8125   $0.0845   $0.0615   $0.0158 
March 2023 Notes(2)   538    350    258,584    -   3/20/2026  $2.50   $1.625   $0.8125   $0.0845   $0.0615   $0.0158 
April 2023 Notes   769    500    615,384    -   3/6/2026  $1.25     N/A    $0.8125   $0.0845   $0.0615   $0.0158 
July 2023 Notes   1,500    975    1,200,000    -   3/6/2026  $1.25     N/A      N/A    $0.0845   $0.0615   $0.0158 
August 2023 Notes   1,000    650    799,999    -   8/4/2026  $1.25     N/A      N/A    $0.0845   $0.0615   $0.0158 
September 2023 Notes(3)   2,885    1,875    26,997,041    -   9/26/2026  $0.13     N/A      N/A    $0.13   $0.0615   $0.0158 
Total Offerings  $10,985   $7,140    31,133,776                                       

 

(1) Warrants include 99,692 issued to the placement agent.
   
(2) Warrants include 43,200 issued to the placement agent.
   
(3) Warrants include 22,189,349 common warrants at $0.13 per share and 4,807,692 pre-funded warrants exercisable at $0.001 per share.

 

F-18

 

 

5. Balance Sheet Details

 

Inventories

 

Inventories consist of the following (in thousands) for the period indicated:

 

   March 31,
2024
   December 31,
2023
 
Raw materials (1)  $526   $520 
Work in process   -    386 
Finished goods (1)   780    791 
Total  $1,306   $1,697 

 

(1) The raw materials and finished goods balances included a combined estimated reserve on obsolescence and excess inventory which might not be sold prior to expiration of $0.2 million and $0.3 million as of March 31, 2024 and December 31, 2023, respectively. These estimates are based upon assumptions about future manufacturing needs and gross sales of Phexxi. Inventory associated with the additional write-down of $1.3 million recorded during the year ended December 31, 2023, was disposed and was no longer in the inventory balance as of December 31, 2023.

 

Prepaid and Other Current Assets

 

Prepaid and other current assets consist of the following (in thousands):

 

   March 31,
2024
   December 31,
2023
 
Insurance  $314   $777 
Research & development   13    13 
Other   295    405 
Total  $622   $1,195 

 

Property and Equipment, Net

 

Property and equipment, net, consists of the following (in thousands):

 

   Useful Life  March 31,
2024
   December 31,
2023
 
Research equipment  5 years  $586   $586 
Computer equipment and software  3 years   151    647 
Construction in-process  -   1,152    1,156 
       1,889    2,389 
Less: accumulated depreciation      (689)   (1,186)
Total, net     $1,200   $1,203 

 

Depreciation expense for property and equipment was immaterial and $0.2 million in the three months ended March 31, 2024 and 2023, respectively.

 

F-19

 

 

Accrued Expenses

 

Accrued expenses consist of the following (in thousands):

 

   March 31,
2024
   December 31,
2023
 
Clinical trial related costs  $2,498   $2,498 
Accrued royalty   1,336    1,146 
Other   741    583 
Total  $4,575   $4,227 

 

6. Fair Value of Financial Instruments

 

Fair Value of Financial Liabilities

 

The following tables summarize the Company’s convertible debt instruments as of March 31, 2024 and December 31, 2023, respectively (in thousands):

 

    Principal   Unamortized
Issuance
    Accrued   Net
Carrying
   Fair Value 
As of March 31, 2024  Amount   Costs   Interest   Amount   Amount   Leveling 
Baker Notes(1)(2)  $101,974   $              -   $-   $101,974   $12,260    Level 3 
Adjuvant Notes(3)   22,500    -    6,601    29,101    N/A    N/A 
December 2022 Notes(1)   959    -    -    959    103    Level 3 
February 2023 Notes (1)   924    -    -    924    99    Level 3 
March 2023 Notes (1)   1,189    -    -    1,189    127    Level 3 
April 2023 Notes (1)   832    -    -    832    89    Level 3 
July 2023 Notes (1)   1,335    -    -    1,335    142    Level 3 
August 2023 Notes (1)   1,054    -    -    1,054    112    Level 3 
September 2023 Notes (1)   3,004    -    -    3,004    320    Level 3 
Totals  $133,771   $-   $6,601   $140,372   $13,252    N/A 

 

    Principal    Unamortized Issuance   Accrued    Net Carrying   Fair Value
As of December 31, 2023  Amount   Costs   Interest   Amount   Amount   Leveling
Baker Notes(1)(2)  $99,460   $     -   $-   $99,460   $13,510   Level 3
Adjuvant Notes(3)   22,500    (27)   6,064    28,537    N/A   N/A
December 2022 Notes(1)   940    -    -    940    118   Level 3
February 2023 Notes (1)   905    -    -    905    118   Level 3
March 2023 Notes (1)   1,204    -    -    1,204    157   Level 3
April 2023 Notes (1)   816    -    -    816    106   Level 3
July 2023 Notes (1)   1,534    -    -    1,534    202   Level 3
August 2023 Notes (1)   1,033    -    -    1,033    136   Level 3
September 2023 Notes (1)   2,945    -    -    2,945    384   Level 3
Totals  $131,337   $(27)  $6,064   $137,374   $14,731   N/A

 

(1) These liabilities are/were carried at fair value in the condensed consolidated balance sheets. As such, the principal and accrued interest was included in the determination of fair value. The related debt issuance costs were expensed.

 

(2) The Baker Notes principal amount includes $16.9 million and $13.7 million of interest paid in-kind as of March 31, 2024, and December 31, 2023, respectively.

 

(3) The Adjuvant Notes are recorded in the condensed consolidated balance sheets at their net carrying amount which includes principal and accrued interest, net of unamortized issuance costs.

 

F-20

 

 

The following tables summarize the Company’s derivative liabilities as of March 31, 2024 and December 31, 2024 as discussed in Note 8 – Stockholders’ Deficit (in thousands):

 

   Fair Value 
   March 31,
2024
   December 31,
2023
   Leveling
Purchase rights  $4,310   $1,926   Level 3
Total derivative liabilities  $4,310   $1,926    

 

Change in Fair Value of Level 3 Financial Liabilities

 

The following table summarizes the changes in Level 3 financial liabilities related to Baker Notes and SSNs measured at fair value on a recurring basis for the three months ended March 31, 2024 (in thousands):

 

   Baker
Notes
(Assigned
to Aditxt;
Reassigned
Back to
Baker;
Note 4)
   Total SSNs
(Note 4)
   Total 
Balance at December 31, 2023  $13,510   $1,221   $14,731 
Extinguishment/conversion   (13,510)   (35)   (13,545)
Balance at issuance   12,390    -    12,390 
Change in fair value presented in the Condensed Consolidated Statements of Comprehensive Operations   (130)   (194)   (324)
Balance at March 31, 2024  $12,260   $992   $13,252 

 

The following table summarizes the changes in Level 3 financial liabilities related to Baker Notes and SSNs measured at fair value on a recurring basis for the three months ended March 31, 2023 (in thousands):

 

   Baker
Notes
   Total SSNs
(Note 4)
   Total 
Balance at December 31, 2022  $39,260   $156   $39,416 
Balance at issuance   -    12    12 
Change in fair value presented in the Condensed Consolidated Statements of Operations   -    (161)   (161)
Change in fair value presented in the Condensed Consolidated Statements of Comprehensive Operations   (15,460)   -    (15,460)
Balance at March 31, 2023  $23,800   $7   $23,807 

 

The following table summarizes the changes in Level 3 financial liabilities related to derivative liabilities measured at fair value on a recurring basis for the three months ended March 31, 2024 (in thousands):

 

   Purchase
Rights
   Derivative
Liabilities
Total
 
Balance at December 31, 2023  $1,926   $1,926 
Balance at issuance   3,275    3,275 
Exercises   (89)   (89)
Change in fair value presented in the Condensed Consolidated Statements of Operations   (802)   (802)
Balance at March 31, 2024  $4,310   $4,310 

 

F-21

 

 

The following table summarizes the changes in Level 3 financial liabilities related to derivative liabilities measured at fair value on a recurring basis for the three months ended March 31, 2023 (in thousands):

 

   Derivative
Liabilities
Previously
Classified
as Equity
Instruments
   May
2022
Public
Offering
Common
Warrants
   June
2022
Baker
Warrants
   December 2022
Warrants
   February
and
March 2023
Warrants
   Purchase
Rights
   Derivative
Liabilities
Total
 
Balance at December 31, 2022  $            1   $303   $170   $107   $           -   $1,095   $1,676 
Balance at issuance   -    -    -    -    6    77    83 
Exercises   -    (6)   -    -    -    (180)   (186)
Change in fair value presented in the Condensed Consolidated Statements of Operations   (1)   (291)   (167)   (106)   -    (886)   (1,451)
Balance at March 31, 2023  $-   $6   $3   $1   $6   $106   $122 

 

Valuation Methodology

 

From the third quarter of 2022 through the second quarter of 2023, the fair value of the Baker Notes issued as described in Note 4 – Debt, and subsequent changes in fair value recorded at each reporting date, was determined by estimating the fair value of the Market Value of Invested Capital (MVIC) of the Company. This was estimated using forms of the cost and market approaches. In the Cost approach, an adjusted net asset value method was used to determine the net recoverable value of the Company, including an estimate of the fair of the Company’s intellectual property. The estimated fair value of the Company’s intellectual property was valued using a relief from royalty method which required management to make significant estimates and assumptions related to forecasts of future revenue, and the selection of the royalty and discount rates. The guideline public company method served as another valuation indicator. In this form of the Market approach, comparable market revenue multiples were selected and applied to the Company’s forward revenue forecast to ultimately derive a MVIC indication. If the resulting fair value from these approaches was not estimated as greater than the contractual payout, the fair value of the Baker Notes became only the Company MVIC available for distribution to this first lien note holder.

 

Starting in the third quarter of 2023, the fair value of the Baker Notes, issued as described in Note 4 – Debt is determined using a Monte Carlo simulation-based model. The Monte Carlo simulation was used to take into account several embedded features and factors, including the exercise of the repurchase right, the Company’s future revenues, meeting certain debt covenants, the maturity term of the note and dissolution. For the dissolution scenario, the cost approach, an adjusted net asset value method was used to determine the net recoverable value of the Company, including an estimate of the fair value of the Company’s intellectual property. The estimated fair value of the Company’s intellectual property was valued using a relief from royalty method which required management to make significant estimates and assumptions related to forecasts of future revenue, and the selection of the royalty (5.0%) and discount (15.0%) rates.

 

The fair value of the Baker Notes is subject to uncertainty due to the assumptions that are used in the Monte Carlo simulation-based model. These factors include but are not limited to the Company’s future revenue, and the probability and timing of the exercise of the repurchase right. The fair value of the Baker Notes is sensitive to these estimated inputs made by management that are used in the calculation.

 

SSNs

 

The fair value of the SSNs issued as described in Note 4 – Debt, were determined using the methods described above in Valuation Methodology, using the residual value of the Company after the fair value of the Baker Notes. The quarterly valuation adjustments for the three months ended March 31, 2024 and 2023 were recorded as a $0.2 million and a $1.6 million change in fair value of financial instruments attributed to credit risk change in the condensed consolidated comprehensive statement of operations.

 

Purchase Rights

 

The Adjuvant Purchase Rights and the May Note Purchase Rights (collectively Purchase Rights) are recorded as derivative liabilities in the condensed consolidated balance sheets. The Purchase Rights are valued using an OPM, like a Black-Scholes Methodology with changes in the fair value being recorded in the condensed consolidated statements of operations. The assumptions used in the OPM are considered level 3 assumptions and include, but are not limited to, the market value of invested capital, the cumulative equity value of the Company as a proxy for the exercise price and the expected term the Purchase Rights will be held prior to exercise and a risk-free interest rate.

 

F-22

 

 

Warrants

 

Warrants previously classified as liabilities were reclassified as equity instruments during the second quarter of 2023 as a result of the Reverse Stock Split. The Company will continue to re-evaluate the classification of its warrants at the close of each reporting period to determine their proper balance sheet classification. The warrants are valued using an OPM based on the applicable assumptions, which include the exercise price of the warrants, time to expiration, expected volatility of our peer group, risk-free interest rate, and expected dividends. The assumptions used in the OPM are considered level 3 assumptions and include, but are not limited to, the market value of invested capital, the cumulative equity value of the Company as a proxy for the exercise price, the expected term the warrants will be held prior to exercise, a risk-free interest rate and probability of change of control event. Additionally, as the warrants are re-priced under certain provisions in the agreements, at each re-pricing event, the Company must value the warrants using a Black-Scholes model immediately prior to and immediately following the re-pricing event. The incremental fair value is recorded as an increase to accumulated deficit and additional paid-in-capital, in accordance with ASC 470.

 

7. Commitments and Contingencies

 

Operating Leases

 

Fleet Lease

 

In December 2019, the Company and Enterprise FM Trust (the Lessor) entered into a Master Equity Lease Agreement whereby the Company leases vehicles to be delivered by the Lessor from time to time with various monthly costs depending on whether the vehicles are delivered for a term of 24 or 36 months, commencing on each corresponding delivery date. The leased vehicles are for use by eligible employees of the Company’s commercial operations team. As of March 31, 2024, there were a total of 20 leased vehicles. The Company maintained a letter of credit as collateral in favor of the Lessor of $0.3 million included in restricted cash, which was released by the Lessor during the first quarter of 2023. The Company determined that the leased vehicles are accounted for as operating leases under ASC 842, Leases (ASC 842). In September 2022, the Company extended the lease term for an additional 12 months for the vehicles with a term of 24 months. The Company determined that such extension is accounted for as a modification, for which the Company reassessed the lease classification and the incremental borrowing rate on the modification date and accounted for accordingly.

 

2020 Lease and the First Amendment

 

On October 3, 2019, the Company entered into an office lease for approximately 24,474 square feet (the High Bluff Premises) pursuant to a non-cancelable lease agreement (the 2020 Lease). The 2020 Lease commenced on April 1, 2020 with an expiry of September 30, 2025, unless terminated earlier in accordance with its terms. The Company provided the landlord with a $0.8 million security deposit in the form of a letter of credit for the High Bluff Premises.

 

On April 14, 2020, the Company entered into the first amendment to the 2020 Lease for an additional 8,816 rentable square feet of the same office location (the Expansion Premises), which commenced on September 1, 2020 with an expiry of September 30, 2025. The Company provided an additional $0.05 million in a letter of credit for the Expansion Premises.

 

On March 20, 2023, the Company received a notice of default from its landlord for failing to timely pay March 2023 rent, resulting in a breach under the agreement. As a result, the Company’s letter of credit in the amount of $0.8 million, in restricted cash, was recovered by the landlord. In June 2023, the Company reached a settlement with the landlord. As a result of such settlement, the Company reversed its associated remaining ROU assets of $3.3 million and lease liabilities of $4.2 million and recognized a gain of $0.2 million.

 

F-23

 

 

2022 Sublease

 

On May 27, 2022, the Company entered into a sublease agreement with AMN Healthcare, Inc. (AMN), pursuant to which the Company agreed to sublease 16,637 rentable square feet of the High Bluff Premises to AMN for a term commencing on June 15, 2022 and ending coterminous with the 2020 Lease on September 30, 2025, in exchange for the sum of approximately $0.1 million per month, subject to an annual 3.5% increase each year. Gross sublease income was zero for the three months ended March 31, 2024 and $0.3 million for the three months ended March 31, 2023. The sublease was terminated along with the settlement of the 2020 Lease in June 2023.

 

Supplemental Financial Statement Information

 

      Three Months Ended March 31, 
Lease Cost (in thousands)  Classification  2024   2023 
Operating lease expense  Research and development  $    1   $66 
Operating lease expense  Selling and marketing   52    159 
Operating lease expense  General and administrative   3    231 
Total     $56   $456 

 

Lease Term and Discount Rate  March 31,
2024
   December 31,
2023
 
Weighted Average Remaining Lease Term (in years)   0.65    0.75 
Weighted Average Discount Rate   12%   12%

 

Maturity of Operating Lease Liabilities (in thousands)  March 31,
2024
 
Remainder of 2024 (9 months)  $56 
Year ending December 31, 2025   11 
Total lease payments   67 
Less imputed interest   (8)
Total  $59 

 

   Three Months Ended March 31, 
Other information (in thousands)  2024   2023 
Cash paid for amounts included in the measurement of lease liabilities:        
Operating cash outflows in operating leases  $64   $610 

 

Other Contractual Commitments

 

In November 2019, the Company entered into a supply and manufacturing agreement with a third-party to manufacture Phexxi, with potential to manufacture other product candidates, in accordance with all applicable current good manufacturing practice regulations. There were no purchases under the supply and manufacturing agreement for the three months ended March 31, 2024 or 2023.

 

F-24

 

 

Contingencies

 

From time to time the Company may be involved in various lawsuits, legal proceedings, or claims that arise in the ordinary course of business. During the year ended December 31, 2023, the Company settled a portion of its trade payables with numerous vendors, which resulted in a $2.1 million reduction in trade payables. As of March 31, 2024, there were no other claims or actions pending against the Company which management believes has a probable, or reasonably possible, probability of an unfavorable outcome. However, the Company may receive trade payable demand letters from its vendors that could lead to potential litigation. As of March 31, 2024, approximately 94% of our trade payables were greater than 90 days past due.

 

On December 14, 2020, a trademark dispute captioned TherapeuticsMD, Inc. v Evofem Biosciences, Inc., was filed in the U.S. District Court for the Southern District of Florida against the Company, alleging trademark infringement of certain trademarks owned by TherapeuticsMD under federal and state law (Case No. 9:20-cv-82296). On July 18, 2022, the Company settled the lawsuit with TherapeuticsMD, with certain requirements which may need to be performed by July 2024.

 

Intellectual Property Rights

 

In 2014, the Company entered into an amended and restated license agreement (the Rush License Agreement) with Rush University Medical Center (Rush University) pursuant to which Rush University granted the Company an exclusive, worldwide license of certain patents and know-how related to its multipurpose vaginal pH modulator technology. For the U.S. patent that the Company licensed from Rush University, multiple Orders Granting Interim Extension (OGIEs) have been received from the United States Patent and Trademark Office (USPTO), currently extending the expiration of this patent to March 2025. Pursuant to the Rush License Agreement, the Company is obligated to pay Rush University an earned royalty based upon a percentage of net sales in the range of mid-single digits until the expiration of this patent. In September 2020, the Company entered into the first amendment to the Rush License Agreement, pursuant to which the Company is also obligated to pay a minimum annual royalty amount of $0.1 million to the extent the earned royalties do not equal or exceed $0.1 million commencing January 1, 2021. Such royalty costs, included in cost of goods sold, were $0.2 million and immaterial for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024 and December 31, 2023, approximately $1.3 million and $1.1 million were included in accrued expenses in the condensed consolidated balance sheets.

 

8. Convertible and Redeemable Preferred Stock and Stockholders’ Deficit

 

Warrants

 

In April and June 2020, pursuant to the Baker Bros. Purchase Agreement, as discussed in Note 4 – Debt, the Company issued warrants to purchase up to 2,732 shares of common stock in a private placement at an exercise price of $4,575 per share. The Second Baker Amendment provides that the exercise price of the Baker Warrants will equal the conversion price of the Baker Notes. The exercise price of the Baker warrants was reset to $0.0158 per share as of March 31, 2024. Subsequent to March 31, 2024, the conversion price adjusted to $0.0154, as discussed in Note 10 – Subsequent Events

 

F-25

 

 

In May 2022, the Company completed an underwritten public offering (the May 2022 Public Offering) which included the issuance of common warrants to purchase 362,640 shares of common stock at a price to the public of $93.75 and the issuance of common warrants to purchase 205,360 shares of common stock at a price to the public of $93.63 (the May 2022 Common Stock Warrants). The May 2022 Common Stock Warrants were exercisable beginning on May 24, 2022 and have a five-year term. Due to features in the May 2022 Common Stock Warrants, including dilution adjustments requiring strike price resets, there are 894,194 May 2022 Common Stock Warrants outstanding as of March 31, 2024 at an exercise price of $0.0158.

 

In June 2022, as required by the Second Baker Amendment, the Company issued the June 2022 Baker Warrants to purchase up to 582,886 shares of the Company’s common stock, $0.0001 par value per share. The June 2022 Baker Warrants have an exercise price of $93.75 per share and a five-year term and were exercisable beginning June 28, 2022. The June 2022 Baker Warrants also contain customary 4.99% and 19.99% limitations on exercise provisions. The exercise price and number of shares issuable upon exercise of the June 2022 Baker Warrants is subject to adjustment for certain dilutive issuances, stock splits and similar recapitalization transactions. The exercise price of these warrants had reset to $0.0158 per share as of March 31, 2024.

 

In February, March, April, July, August, and September 2023, pursuant to the SSNs as discussed in Note 4 – Debt, the Company issued warrants to purchase up to 1,152,122 shares of the Company’s common stock at an exercise price of $2.50 per share, up to 2,615,383 shares of the Company’s common stock at an exercise price of $1.25 per share and up to 22,189,349 shares of the Company’s common stock at an exercise price of $0.13 per share. The exercise price of these warrants reset to $0.0158 per share as of March 31, 2024.

 

On December 21, 2023, warrants to purchase up to 9,972,074 shares of the Company’s common stock were exchanged for 613 shares of the Company’s Series F-1 Shares.

 

As of March 31, 2024, warrants to purchase up to 20,807,543 shares of the Company’s common stock remain outstanding at a weighted average exercise price of $2.42 per share. In accordance with ASC 815, certain warrants previously classified as equity instruments were determined to be liability classified (the Reclassified Warrants) due to the Company having an insufficient number of authorized shares as of December 31, 2022; however, the impacted warrants were reclassified back to as equity instruments during the second quarter of 2023 as a result of the May 2023 Reverse Stock Split. During the three months ended March 31, 2024, the Company obtained waivers from a majority of the convertible instrument holders, removing the requirement for shares to be reserved for conversion of their instruments, which will prevent the instruments from needing to be liability classified due to an insufficient number of authorized shares going forward. The Company will continue to re-evaluate the classification of its warrants at the close of each reporting period to determine the proper balance sheet classification for them. These warrants are summarized below:

  

Type of Warrants  Underlying
common stock to
be Purchased
   Exercise
Price
   Issue Date  Exercise Period
Common Warrants   4   $6,918.75   June 11, 2014  June 11, 2014 to June 11, 2024
Common Warrants   451   $14,062.50   May 24, 2018  May 24, 2018 to May 24 2025
Common Warrants   888   $11,962.50   April 11, 2019  October 11, 2019 to April 11, 2026
Common Warrants   1,480   $11,962.50   June 10, 2019  December 10, 2019 to June 10, 2026
Common Warrants   1,639   $0.0158   April 24, 2020  April 24, 2020 to April 24, 2025
Common Warrants   1,092   $0.0158   June 9, 2020  June 9, 2020 to June 9, 2025
Common Warrants   8,003   $735.00   January 13, 2022  March 1, 2022 to March 1, 2027
Common Warrants   8,303   $897.56   March 1, 2022  March 1, 2022 to March 1, 2027
Common Warrants   6,666   $309.56   May 4, 2022  May 4, 2022 to May 4, 2027
Common Warrants   894,194   $0.0158   May 24, 2022  May 24, 2022 to May 24, 2027
Common Warrants   582,886   $0.0158   June 28, 2022  May 24, 2022 to June 28, 2027
Common Warrants   49,227   $0.0158   December 21, 2022  December 21, 2022 to December 21, 2027
Common Warrants   130,461   $0.0158   February 17, 2023  February 17, 2023 to February 17, 2028
Common Warrants   258,584   $0.0158   March 20, 2023  March 20, 2023 to March 20, 2028
Common Warrants   369,231   $0.0158   April 5, 2023  April 5, 2023 to April 5, 2028
Common Warrants   349,463   $0.0158   July 3, 2023  July 3, 2023 to July 3, 2028
Common Warrants   615,384   $0.0158   August 4, 2023  August 4, 2023 to August 4, 2028
Common Warrants   12,721,893   $0.0158   September 27, 2023  September 27, 2023 to September 27, 2028
Prefunded Common Warrants   4,807,694   $0.0010   September 27, 2023  September 27, 2023 to September 27, 2028
Total   20,807,543            

 

Preferred Stock

 

Effective December 15, 2021, the Company amended and restated its certificate of incorporation, under which the Company is currently authorized to issue up to 5,000,000 shares of total preferred stock, including the authorized convertible and redeemable preferred stock designated for Series B-1 and B-2, Series C, Series E-1, and Series F-1, and nonconvertible and redeemable preferred stock (Series D), par value $0.0001 per share.

 

F-26

 

 

Convertible and Redeemable Preferred Stock

 

On August 7, 2023, the Company filed a Certificate of Designation of Series E-1 Convertible Preferred Stock (E-1 Certificate of Designation), par value $0.0001 per share (the Series E-1 Shares). An aggregate of 2,300 shares was authorized. The Series E-1 Shares are convertible into shares of common stock at a conversion price of $0.40 per share and are both counted toward quorum on the basis of and have voting rights equal to the number of shares of common stock into which the Series E-1 Shares are then convertible. The Series E-1 Shares are senior to all common stock with respect to preferences as to dividends, distributions and payments upon a dissolution event. In the event of a liquidation event, the Series E-1 Shares are entitled to receive an amount per share equal to the Black Scholes Value as of the liquidation event plus the greater of 125% of the conversion amount (as defined in the Certificate of Designation) and the amount the holder of the Series E-1 Shares would receive if the shares were converted into common stock immediately prior to the liquidation event. If the funds available for liquidation are insufficient to pay the full amount due to the holders of the Series E-1 Shares, each holder will receive a percentage payout. The Series E-1 Shares are entitled to dividends at a rate of 10% per annum or 12% upon a triggering event. Dividends are payable in shares of common stock and may, at the Company’s election, be capitalized and added to the principal monthly. The Series E-1 Shares also have a provision that allows them to be converted to common stock at a conversion rate equal to the Alternate Conversion Price (as defined in the E-1 Certificate of Designation) times the number of shares subject to conversion times the 25% redemption premium in the event of a Triggering Event (as defined in the E-1 Certificate of Designation) such as in a liquidation event. The Series E-1 Shares are mandatorily redeemable in the event of bankruptcy.

 

On August 7, 2023, certain investors party to the December 2022 Notes and the February 2023 Notes exchanged $1.8 million total in principal and accrued interest under the outstanding convertible promissory notes for 1,800 shares of Series E-1 Shares (the August 2023 Preferred Stock Transaction). Per the E-1 Certificate of Designation, the conversion rate can also be adjusted in several future circumstances, such as on certain dates after the exchange date and upon the issuance of additional convertible securities with a lower conversion rate or in the instance of a Triggering Event. As such, the conversion price as of March 31, 2024 was adjusted to $0.0158 per share. The Series E-1 Shares are classified as mezzanine equity within the condensed consolidated balance sheets in accordance with ASC 480 because of a fixed 25% redemption premium upon a Triggering Event and no mandatory redemption feature. During the year ended December 31, 2023, $1.8 million was recorded as an increase to additional paid-in-capital for the preferred shares in the condensed consolidated statement of convertible and redeemable preferred stock and stockholders’ deficit related to the August 2023 Preferred Stock Transaction. During the three months ended March 31, 2024, an immaterial deemed dividend was recorded as an increase to the number of Series E-1 Shares outstanding.

 

On December 11, 2023, the Company filed a Certificate of Designation of Series F-1 Convertible Preferred Stock (F-1 Certificate of Designation), par value $0.0001 per share (the Series F-1 Shares). An aggregate of 95,000 shares was authorized. The Series F-1 Shares are convertible into shares of common stock at a conversion price of $0.0635 per share and do not have the right to vote on any matters presented to the holders of the Company’s common stock. The Series F-1 Shares are senior to all common stock and subordinate to the Series E-1 Shares with respect to preferences as to distributions and payments upon a dissolution event. In the event of a liquidation event, the Series F-1 Shares are entitled to receive an amount per share equal to the Black Scholes Value as of the liquidation event plus the greater of 125% of the conversion amount (as defined in the F-1 Certificate of Designation) and the amount the holder of the Series F-1 Shares would receive if the shares were converted into common stock immediately prior to the liquidation event. If the funds available for liquidation are insufficient to pay the full amount due to the holders of the Series F-1 Shares, each holder will receive a percentage payout. The Series F-1 Shares are not entitled to dividends. The Series F-1 Shares also have a provision that allows them to be converted to common stock at a conversion rate equal to the Alternate Conversion Price (as defined in the F-1 Certificate of Designation) times the number of shares subject to conversion times the 25% redemption premium in the event of a Triggering Event (as defined in the F-1 Certificate of Designation) such as in a liquidation event. The Series F-1 Shares are mandatorily redeemable in the event of bankruptcy.

 

On December 21, 2023, the Company issued a total of 22,280 Series F-1 Shares to certain investors, including 613 shares exchanged for warrants to purchase up to 9,972,074 shares of the Company’s common stock and 21,667 shares to exchange a partial value of the outstanding purchase rights. The holders of the Series F-1 Shares immediately exchanged their Series F-1 Shares into Aditxt’s Series A-1 preferred stock and, as a result, Aditxt currently holds all 22,280 outstanding Series F-1 Shares. The Series F-1 Shares are to be cancelled upon the consummation of the Merger. As discussed in Note 10 – Subsequent Events, on April 26, 2024, the Company terminated the Merger Agreement but entered into the Reinstatement and Fourth Amendment to the Merger Agreement on May 2, 2024.

 

F-27

 

 

Nonconvertible and Redeemable Preferred Stock

 

On December 16, 2022, the Company filed a Certificate of Designation of Series D Non-Convertible Preferred Stock (the D Certificate of Designation), par value $0.0001 per share (the Series D Preferred Shares). An aggregate of 70 shares was authorized; these shares were not convertible into shares of common stock, had limited voting rights equal to 1% of the total voting power of the then-outstanding shares of common stock entitled to vote, were not entitled to dividends, and were required to be redeemed by the Company once its shareholders approved a reverse split, as described in the D Certificate of Designation. All 70 shares of the Series D Preferred were subsequently issued in connection with the December 2022 Securities Purchase Agreement as discussed in Note 4 – Debt. The Series D Preferred Shares were redeemed in July 2023.

 

Common Stock

 

Effective September 14, 2023, the Company further amended its amended and restated certificate of incorporation to increase the number of authorized shares of common stock to 3,000,000,000 shares.

 

Purchase Rights

 

On September 15, 2022, the Company entered into certain exchange agreements with the Adjuvant Purchasers and the May 2022 Notes Purchasers to exchange, upon request, the Purchase Rights for an aggregate of 942,080 shares of the Company’s common stock. The number of right shares for each Purchase Right is initially fixed at issuance, but subject to certain customary adjustments for certain dilutive Company equity issuances until the second anniversary of issuance. These Purchase Rights expire on June 28, 2027. Refer to Note 6 – Fair Value of Financial Instruments for the accounting treatment of the Purchase Rights. In 2023, the Company subsequently signed an additional agreement with the holders of the Purchase Rights upon which the total aggregate value of the Purchase Rights is fixed at $24.7 million, to be paid in a variable number of shares based on the current exercise price. On December 21, 2023, the Company issued 21,667 shares of the Series F-1 Shares in exchange for a partial value of certain purchase rights, as described above.

 

In connection with the SSNs issuances, during the three months ended March 31, 2024 and 2023, the Company increased the number of outstanding Purchase Rights by 1,145,333,158 and 10,467,332, respectively, due to the reset of their exercise price. This was recorded as a loss on issuance of financial instruments in the amount of $3.3 million and $0.1 million in the condensed consolidated statements of operations for the respective periods. The exercise price will be further adjusted if any other convertible instruments have price resets.

 

The Company issued 17,725,000 shares of common stock upon the exercise of certain Purchase Rights during the three months ended March 31, 2024. As of March 31, 2024, Purchase Rights of 1,530,645,242 shares of the Company’s common stock remained outstanding.

 

F-28

 

 

Common Stock Reserved for Future Issuance

 

Common stock reserved for future issuance is as follows in common equivalent shares as of March 31, 2024:

 

Common stock issuable upon the exercise of stock options outstanding   3,747 
Common stock issuable upon the exercise of common stock warrants   10,598,205 
Common stock available for future issuance under the 2019 ESPP   509 
Common stock available for future issuance under the Amended and Restated 2014 Plan   5,789 
Common stock available for future issuance under the Amended Inducement Plan   609 
Common stock reserved for the exercise of purchase rights   722,646,377 
Common stock reserved for the conversion of convertible notes   148,541,458 
Common stock reserved for the conversion of series E-1 preferred stock   33,750,860 
Total common stock reserved for future issuance(1)   915,547,554 

 

(1) The potentially dilutive securities in Note 2 – Summary of Significant Accounting Policies includes all potentially dilutive securities that are not included in the diluted EPS as per U.S. GAAP, whereas the total common stock reserved for future issuance in the table above includes the shares that must legally be reserved based on the applicable instruments’ agreements.

 

9. Stock-based Compensation

 

Equity Incentive Plans

 

The following table summarizes stock-based compensation expense related to stock options granted to employees, non-employee directors and consultants included in the condensed consolidated statements of operations as follows (in thousands):

 

   Three Months Ended March 31, 
   2024   2023 
Research and development  $16   $40 
Selling and marketing   35    57 
General and administrative   186    320 
Total  $237   $417 

 

Stock Options

 

There were no shares of stock options granted during the three months ended March 31, 2024 or 2023. As of March 31, 2024, unrecognized stock-based compensation expense for employee stock options was approximately $0.9 million, which the Company expects to recognize over a weighted-average remaining period of 1.4 years, assuming all unvested options become fully vested.

 

Employee Stock Purchase Plan

 

The purchase price under the 2019 ESPP is 85% of the lesser of the fair market value of the common stock on the first or the last business day of an offering period. The maximum number of shares of common stock that may be purchased by any participant during an offering period is equal to $25,000 divided by the fair market value of the common stock on the first business day of an offering period. In October 2022, the Board suspended future offering periods.

 

F-29

 

 

Restricted Stock Awards

 

There were no shares of performance-based RSAs granted in 2023 to the Company’s executive management team.

 

For performance-based RSAs, (i) the fair value of the award is determined on the grant date; (ii) the Company assesses the probability of achieving each individual milestone associated with the award using reasonable assumptions based on the Company’s operation performance towards each milestone; (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met; and (iv) the Company reassesses the probability of achieving each individual milestone at each reporting date, and any change in estimate is accounted for through a cumulative adjustment in the period when the change in estimate occurs. Non-performance based RSAs are valued at the fair value on the grant date and the associated expenses will be recognized over the vesting period.

 

As of March 31, 2024, there was no unrecognized noncash stock-based compensation expense related to unvested RSAs.

 

10. Subsequent Events

 

Termination and Reinstatement of Merger Agreement

 

On April 26, 2024, the Company delivered a termination notice to Aditxt notifying it that the Company was exercising its right to terminate the Merger Agreement effective April 26, 2024 (the Termination Notice), in accordance with Section 8.1(f) of the Merger Agreement, as revised in the third amendment to the Merger Agreement, made on February 29, 2024.

 

Reinstatement and Amendment of Merger Agreement

 

On May 2, 2024, the Company, the Merger Sub and Aditxt entered into the Reinstatement and Fourth Amendment to the Merger Agreement (the “Fourth Amendment”) in order to waive and amend, among other things, several provisions. This Fourth Amendment reinstates the Merger Agreement, as amended by the Fourth Amendment, as if never terminated. In consideration of the Fourth Amendment, Aditxt agreed to pay the Company $1.0 million (the Initial Payment). The key financial terms in the Fourth Amendment were to revise section 6.10 of the Merger Agreement such that, after the Initial Payment, and upon the closing of each subsequent capital raise by Aditxt (each a Parent Subsequent Capital Raise), Aditxt shall purchase that number of shares of the Company’s Series F-1 Preferred Stock, par value $0.0001 per share (the Series F-1 Preferred Stock), equal to forty percent (40%) of the gross proceeds of such Parent Subsequent Capital Raise divided by 1,000, up to a maximum aggregate amount of $2.5 million or 2,500 shares of Series F-1 Preferred Stock. A maximum of $1.5 million shall be invested in Evofem prior to June 17, 2024 and $1.0 million prior to July 1, 2024.

 

Conversion Price Reset

 

At the close of market on April 19, 2024, the conversion price for certain outstanding financial instruments (as described in Note 4 – Debt and Note 8 – Stockholders’ Deficit) was adjusted to $0.0154 as per provisions in their underlying agreements.

 

Warrants and Purchase Rights Exercises and Notes Conversions

 

Subsequent to March 31, 2024, the Company 6,150,000 Purchase Rights were exercised in a cashless transaction for an equivalent number of shares of common stock. There were also cashless conversions whereby $0.1 million in convertible notes were converted to 7,200,000 shares of common stock.

 

 

F-30