EVOFEM BIOSCIENCES, INC. Management’s Discussion and …

You should read the following discussion and analysis of our financial conditionand results of operations together with our financial statements and relatednotes appearing elsewhere in this Annual Report. Some of the informationcontained in this discussion and analysis is set forth elsewhere in this AnnualReport, including information with respect to our plans and strategy for ourbusiness and related financing, includes forward-looking statements that involverisks and uncertainties. As a result of many factors, including those factorsset forth in the “Risk Factors” section of this Annual Report, our actualresults could differ materially from the results described in, or implied by,the forward-looking statements contained in the following discussion andanalysis.OverviewWe are a San Diego-based commercial-stage biopharmaceutical company committed todeveloping and commercializing innovative products to address unmet needs inwomen’s sexual and reproductive health.

Our first commercial product, Phexxi,was approved by the FDA on May 22, 2020. It is the first and only FDA-approved,hormone-free, woman-controlled, on-demand prescription contraceptive gel forwomen. We commercially launched Phexxi in September 2020 in the United States.We intend to commercialize Phexxi in all other global markets throughpartnerships or licensing agreementsRecent DevelopmentsOn February 10, 2023, Jenny Yip notified Evofem Biosciences, Inc., a Delawarecorporation (the Company), of her resignation as member of the Company’s boardof directors (the Board), effective immediately.

Ms. Yip’s resignation is notthe result of any dispute or disagreement with the Company on any matterrelating to the Company’s operations, policies or practicesIn February, March and April 2023, we entered into securities purchaseagreements with certain investors providing for the sale and issuance of seniorsecured convertible notes (collectively, the 2023 SPAs). The 2023 SPAs included(i) convertible promissory notes with aggregate original principal amounts ofapproximately £1.4 million, £0.6 million, £0.5 million and £0.8 million,respectively (the 2023 Notes), and (ii) warrants to purchase an aggregate69,230,769, 30,000,000, 26,923,077 and 76,923,077 shares of common stock,respectively (the 2023 Warrants and collectively, the 2023 Offerings).

The 2023Offerings closed on February 17, 2023 (the February 2023 Closing), March 13,2023 March 20, 2023 (the March 2023 Closing) and April 5, 2023 (the April 2023Closing), respectively, with net proceeds to the Company, after deductingoffering expenses, of approximately £0.7 million, £0.3 million, £0.3 million,and £0.5 million, respectively. The 2023 SPAs also included a RegistrationRights Agreement requiring us to register the common stock underlying the 2023Notes and 2023 Warrants within the timeframes specified therein.Upon the April 2023 Closing, the conversion and strike prices, as applicable, ofthe Baker Notes, Baker Warrants, the May 2022 Common Warrants, the June 2022Baker Warrants, the Adjuvant Notes, the December 2022 Notes and Warrants, andthe Notes and Warrants in the February and March 2023 Closing reset to £0.0065per share, accordingly. Additionally, the Company’s outstanding Purchase Rightsincreased by approximately 3.1 billion since December 31, 2022.On March 7, 2023, Baker Bros.

Advisors, LP (the Designated Agent) provided aNotice of Event of Default and Reservation of Rights (the Notice of Default)relating to the Securities Purchase and Security Agreement dated April 23, 2020,and subsequently amended (SPA), by and amount we, Designated Agent, theGuarantors and Baker Purchasers. The Notice of Default claims that the Companyhas failed to maintain the “Required Reserve Amount” as required by Section 2.7of the Third Amendment to the Securities Purchase Agreement and Section 8.1(e)of the SPA. The Designated Agent claims such failure constitutes an immediateEvent of Default pursuant to Section 9.1(e) of the SPA.

The Designated Agent, atthe direction of the Baker Purchasers, has accelerated repayment of theoutstanding balance payable and elected its remedies pursuant to Section 5.07(b)of the Securities Purchase Agreement. As a result, approximately £92.8 millionrepresenting two times the sum of the outstanding balance and all accrued andunpaid interest thereon and all other amounts due under the SPA and otherdocuments is due and payable within three business days of receipt of the Noticeof Default. We disagree with the Designated Agent’s claims and have invited theDesignated Agent to reconsider and rescinded its Notice of Default and requestfor payment, for which no formal request for payment has yet been made.

We willexplore all available options in resolving this matter.On March 15, 2023, we held a Special Meeting of Stockholders in which ourstockholders approved an amendment to our Certificate of Incorporation toeffectuate a reverse stock split of the outstanding shares of our common stockby a ratio of not less than 1-for-20 and not more than 1-for-125 at any time onor prior to March 15, 2024, with the exact ratio to be set at a whole numberwithin such range by our board of directors (the 2023 Reverse Stock Split).On March 20, 2023 our Board of Directors approved a reduction in force (the March 2023 RIF) intended to conserve our current cash resources and manage operating expenses. We reduced our current workforce, resulting in an overall 39% reduction of payroll expenses including (i) salary cuts for certain employees, (ii) elimination of eight office and management 81——————————————————————————–positions including the elimination of the Chief Commercial Officer roleeffective March 17, 2023; and (iii) reduction of the Chief Executive Officer’ssalary by 40%. We expect annualized future cost savings from the reduction inforce to be approximately £4.3 million, which we intend to use to support ouroperations.In connection with the March 2023 RIF, we estimate we will incur aggregatecharges of approximately £0.1 million primarily consisting of notice period andseverance payments, employee benefits and related costs, which charges wereincurred in the first quarter of 2023.

We expect the reduction in forceassociated with the March 2023 RIF will be complete by the end of the secondquarter of 2023.On March 7, 2023, Baker Bros. Advisors, LP (the Designated Agent) provided aNotice of Event of Default and Reservation of Rights (the Notice of Default)relating to the Securities Purchase and Security Agreement dated April 23, 2020,and subsequently amended (SPA), by and amount the Company, Designated Agent, theGuarantors and Baker Purchasers. The Notice of Default claims that the Companyhas failed to maintain the “Required Reserve Amount” as required by Section 2.7of the Third Amendment to the Securities Purchase Agreement and Section 8.1(e)of the SPA.

The Designated Agent claims such failure constitutes an immediateEvent of Default pursuant to Section 9.1(e) of the SPA. The Designated Agent, atthe direction of the Baker Purchasers, has accelerated repayment of theoutstanding balance payable and elected its remedies pursuant to Section 5.07(b)of the Securities Purchase Agreement. As a result, approximately £92.8 millionrepresenting two times the sum of the outstanding balance and all accrued andunpaid interest thereon and all other amounts due under the SPA and otherdocuments is due and payable within three business days of receipt of the Noticeof Default.

The Company disagrees with the Designated Agent’s claims and hasinvited the Designated Agent to reconsider and rescinded its Notice of Defaultand request for payment, for which no formal request for payment has yet beenmade. The Company will explore all available options in resolving this matter.On April 24, 2023, Gillian Greer, PhD., notified the Company of her resignation as member of the Company’s board of directors (the Board), effective immediately. Dr.

Greer’s resignation is not the result of any dispute or disagreement with the Company on any matter relating to the Company’s operations, policies or practices.Phexxi as a Contraceptive; Commercial StrategiesIn September 2020, we commercially launched Phexxi. Our sales force promotesPhexxi directly to obstetrician/gynecologists and their affiliated healthprofessionals, who collectively write the majority of prescriptions forcontraceptive products. Our sales force comprises approximately 16 regionalsales representatives, three business managers and a VP of sales, supported by aself-guided virtual health care provider (HCP) learning platform.

Additionally,we offer women direct access to Phexxi via our telehealth platform. Using theplatform, women can directly meet with an HCP to determine their eligibility fora Phexxi prescription and, if eligible, have the prescription written by theHCP, filled, and mailed directly to them by a third party pharmacy.Our comprehensive commercial strategy for Phexxi includes marketing and productawareness campaigns targeting women of reproductive potential in the U.S.,including the approximately 23 million women who are not using hormonalcontraception and the approximately 18.8 million women who are using aprescription contraceptive, some of whom, particularly pill users, may be readyto move to an FDA-approved, non-invasive hormone-free contraceptive, as well ascertain identified target HCP segments. In addition to marketing and productawareness campaigns, our commercial strategy includes payer outreach andexecution of our consumer digital and media strategy.According to our post-commercial launch market research, HCPs indicated theywould recommend Phexxi to approximately 60% of patients who are currently usingnatural contraceptive methods, approximately 58% of patients who are currentlyusing over-the-counter contraceptive products and approximately 26% of patientswho are currently using prescription contraception or methods requiring an HCPto perform a procedure.

Additional research into the demographics of more than1,300 women who are using Phexxi revealed that 60% of Phexxi users are betweenthe ages of 18 to 34 years of age. Among the subset of Phexxi users for whomprior contraceptive data is available (n=413), 39% of women who had recentlystarted Phexxi switched over from either an oral contraceptive, hormonepatch/ring, or long-acting reversible contraception.On February 14, 2021, we launched a direct-to-consumer advertising campaign,known as “Get Phexxi,” designed to increase awareness and educate women on thebenefits of Phexxi. The campaign highlights some of the struggles women facewhen choosing among the many available methods of contraception, including thelack of control with condoms, daily use of the pill, and abstinence required forcycle tracking.On September 9, 2021, we launched a national brand ambassador campaign called “House Rules” designed to broaden awareness and drive uptake of Phexxi.

The House Rules campaign significantly raised our target audience awareness of Phexxi, while also driving women to their HCP to request a trial. More importantly, it also helped increase new HCPs recommending and prescribing Phexxi. 82——————————————————————————–We continue working to increase the number of lives covered and to gain apreferred formulary position for Phexxi. We gained coverage for 32.5 millionlives in 2022 and added 16.3 million lives in the first quarter of 2023.Coverage includes 60% of commercial lives, including 16.4 million lives coveredat no out-of-pocket cost as of February 10, 2023 and approximately 13.7 millionlives covered under our December 2020 contract award from the U.S.

Department ofVeterans Affairs. As of February 2023, the Phexxi approved claims rate increasedto 80%.On January 1, 2021, as a result of our participation in the Medicaid NationalDrug Rebate Program, the U.S. Medicaid population gained access to Phexxi.Medicaid provides health coverage to approximately 68 million members, includingapproximately 16.8 million women between 19 to 49 years of age.Phexxi is classified in the databases and pricing compendia of Medi-Span andFirst Databank, two major drug information databases that payers can consult forpricing and product information, as the first and only “Vaginal pH Modulator.”As of January 1, 2023, most insurers and pharmacy benefit managers (PBMs) mustprovide coverage, with no out-of-pocket costs (e.g. £0 copay) to the subscriberor dependent, for FDA-approved contraceptive products, like Phexxi, prescribedby healthcare providers.As a result, to comply with these Guidelines, payers are increasingly covering Phexxi by:-Adding Phexxi to formulary (commercial insurers) or preferred drug list (Medicaid)-Removing the requirement for a Prior Authorization letter from the HCP (commercial insurers)-Moving Phexxi to £0 copay (commercial insurers)While highly favorable to Phexxi, the updated HSRA Guidelines remove the impetusfor the FDA to update its Birth Control Guide (the Guide) to include methodsthat were approved by the FDA after the development of the Guide more than adecade ago, including the vaginal pH modulator (Phexxi).

We believe there isstill merit to the Guide being current and accurate, and continue to work withthe FDA’s Office of Women’s Health to update the Guide.The Guide was developed and is used as an educational tool by manyobstetrician/gynecologists to assist in counseling patients on theircontraceptive options and to help them find the method that best suits theirneeds. Methods not on the current, outdated Guide may be underrepresented inthese contraceptive counseling dialogues. We therefore believe the Guide shouldinclude all FDA-approved methods of birth control.Further, even though the FDA Guide was intended as an educational tool, certaininsurers have used it to block coverage of methods not included on the Guide.While this is explicitly prohibited by the current HSRA Guidelines, and therehas been considerable progress since January 1, 2023, two notable plans continueto flout the law.With the FDA not yet moving to update its Guide, in 2022 Evofem developed andintroduced a new educational chart that provides high-level information aboutbirth control methods that are currently available to women in the UnitedStates, adding new categories including vaginal pH modulator.

This neweducational tool has been extremely well received and has had a positive impactwith HCPs and patients alike.Research and DevelopmentOur pipeline includes programs to evaluate vaginal pH modulators and other newproduct candidates for a variety of women’s health concerns, including thoselisted below. These programs are on currently hold as we focus resources onactivities intended to increase Phexxi revenues.EVO100 for the Prevention of Chlamydia and GonorrheaUntil October 2022, we were evaluating EVO100 for the prevention of urogenitalchlamydia and gonorrhea in women. Chlamydia and gonorrhea are among the manybacterial and viral pathogens that require a higher pH environment to thrive. in2018, the CDC reported that infections with these two sexually transmittedpathogens cost the U.S. healthcare system £1 billion, in aggregate direct andindirect costs.

There are no FDA-approved drugs to prevent these sexuallytransmitted diseases (STIs), and we believe there is a clear need for newprophylactics given the rising incidence and increasing antibiotic resistance ofgonorrhea. We therefore advanced our program to investigate the potential forEVO100 to prevent vaginal infection with these two common pathogens.Our Phase 2B/3 trial (AMPREVENCE) achieved its primary and secondary endpoints,demonstrating statistically significant reductions in chlamydia and gonorrheainfections of 50% and 78%, respectively, in women receiving EVO100 vs.

83——————————————————————————–placebo. Based on these highly positive clinical outcomes we initiated a Phase 3clinical trial (EVOGUARD) to evaluate EVO100 for these potential indications in2020.

This randomized, placebo-controlled clinical trial enrolled 1,903 womenwith a prior chlamydia or gonorrhea infection who were at risk for futureinfection.On October 11, 2022, we reported that EVOGUARD did not meet its primary efficacyendpoint. We believe COVID-19 related changes in clinical site operations,subject behavior and actions including deviations from following the clinicalstudy protocol requirements related to STI acquisition, detection, andprevention contributed to this outcome. The product safety profile wasconsistent with what has been observed in prior clinical trials, and only twowomen (0.1%) in the study discontinued due to adverse events.

We believe thereis a path forward for EVO100 and may in the future conduct a new Phase 3clinical trial of EVO100 for these potential indications. However, due tofinancial constraints, we discontinued investment in this clinical program inOctober 2022.EVO200 Vaginal pH Modulator for Bacterial VaginosisOur investigational candidate for the reduction of recurrent bacterial vaginosis(BV), EVO200 vaginal gel, uses the same proprietary vaginal pH modulatorplatform as Phexxi. In a Phase 1 dose-finding trial for this indication, thehighest dose formulation of the study drug demonstrated reduced vaginal pH forup to seven days following a single administration.

We may decide to pursuefurther development of EVO200 in the future. The FDA has designed EVO200 as aQualified Infectious Disease Product (QIDP) for this indication, which providesseveral important potential advantages including, but not limited to, longermarket exclusivity.Multipurpose Prevention Technology Candidate for HIV PreventionIn December 2021, we launched a collaboration with Orion Biotechnology CanadaLtd. (Orion) to evaluate the compatibility and stability of Orion’s novel CCR5antagonist, OB-002, in Phexxi with the goal of developing a MultipurposePrevention Technology (MPT) product candidate for indications including theprevention of HIV in women. Assuming positive preclinical results, Evofem andOrion will seek government and philanthropic funding for subsequent clinicaltrials of any resulting MPT vaginal gel product candidate.Financial Operations OverviewNet Product SalesOur revenue recognition is based on unit shipments from our third-partylogistics warehouse to our customers, which consist of wholesale distributors,retail pharmacies, telehealth companies Twentyeight Health (formerlySimpleHealth) and the Pill Club, and a mail-order specialty pharmacy.

We haverecognized net product sales in the United States since the commercial launch ofPhexxi in September 2020. The year ended December 31, 2022 was our second fullyear of product sales.For the year ended December 31, 2022, there was an approximate 26% increase inshipments to wholesale distributors and pharmacies compared to the year endedDecember 31, 2021. The increase in shipments coupled with improvements in grossto net adjustments drove an increase in net product sales of approximately 104%.Phexxi outperformed the newer branded contraceptive market and the launch of ourHouse Rules campaign in September 2021 has increased Phexxi awareness,consideration, and prescriptions.

Gross revenues, as discussed in Note 3-Revenue , were adjusted for variable consideration, including our patientsupport programs.We intend to out-license commercialization rights for Phexxi to one or morepharmaceutical companies or other qualified potential partners for countries orregions outside of the United States. We are currently in discussion withpotential partners for various geographies. We cannot forecast when or if thesearrangements will be secured, the structure or potential amount of revenues fromthese arrangements, whether upfront, milestone-related or related to futurePhexxi sales (assuming approval of Phexxi for commercial sale outside of theUnited States) or to what degree these arrangements would affect our developmentplans, future revenues and overall capital requirements.In October 2021, we submitted the registration for our hormone-freecontraceptive vaginal gel to the Mexican Regulatory Agency Comision Federal parala Proteccion contra Riesgos Sanitarios.

In addition to submitting forregistration in Mexico, we have also submitted marketing applications for Phexxiunder the trademark Femidence(TM) in Nigeria, Ethiopia, and Ghana. These were thefirst of several strategic regulatory submissions planned under Evofem’s 2020Global Health Agreement with Adjuvant Capital.In October 2022, Phexxi was approved in Nigeria, where the product will be potentially marketed under the brand name Femidence(TM). This is the first regulatory approval for the contraceptive vaginal gel outside the U.S. 84——————————————————————————–Cost of Goods SoldInventory costs include all purchased materials, direct labor and manufacturingoverhead.

In addition, we are obligated to pay quarterly royalty paymentspursuant to our license agreement with Rush University, in amounts equal to asingle-digit percentage of the gross amounts we receive on a quarterly basis,less certain deductions incurred in the quarter based on a sliding scale. We arealso obligated to pay a minimum annual royalty amount of £100,000 to the extentthese earned royalties do not equal or exceed £100,000 in a given year. Aminimum annual royalty amount of £100,000 was first required for the annualperiod commencing on January 1, 2021.

Such royalty costs were £1.1 million and£0.2 million for the years ended December 31, 2022 and 2021, respectively, andwas included in the costs of goods sold in the consolidated financialstatements.Operating ExpensesResearch and Development ExpensesOur research and development expenses primarily consist of costs associated withthe continuous improvements related to Phexxi commercialization efforts. Theseexpenses include:ocontinuous improvements of manufacturing and analytical efficiency;oon-going product characterization and process optimization;oalternative raw material evaluation to secure an uninterrupted supply chain andreduce cost of goods sold;oemployee-related expenses, including salaries, benefits, travel and noncashstock-based compensation expense; andofacilities, depreciation and other allocated expenses, which include direct andallocated expenses for rent and maintenance of facilities, depreciation ofleasehold improvements and equipment, and research and other supplies.In 2022 and 2021 research and development expenses also included costs associated with the clinical development of EVO100 for the prevention of chlamydia and gonorrhea, including:oexternal development expenses incurred under arrangements with third parties,such as fees paid to clinical research organizations (CROs) relating to ourclinical trials, costs of acquiring and evaluating clinical trial data such asinvestigator grants, patient screening fees, laboratory work and statisticalcompilation and analysis, and fees paid to consultants;ocosts to acquire, develop and manufacture clinical trial materials, includingfees paid to contract manufacturers;ocosts related to compliance with drug development regulatory requirements;We expense internal and third-party research and development expenses as incurred. The following table summarizes research and development expenses by product candidate (in thousands): Years Ended December 31, 2022 2021Allocated third-party development expenses:Phexxi for prevention of chlamydia/gonorrhea- Phase 3 (EVOGUARD) £ 17,374 £ 23,779 Unallocated internal research and development expenses: Noncash stock-based compensation expenses 553 1,357Payroll and related expenses 3,820 4,967Outside services costs 1,240 1,696Other 2,045 1,330Total unallocated internal research and development expenses 7,658 9,350Total research and development expenses £ 25,032 £ 33,129Costs for our clinical development programs and clinical trials in general arevery difficult to predict and may vary significantly between clinical trials andover the life of a program owing to the following:othe phase of development of the product candidate;othe number of patients participating in the trial;oper patient trial costs;othe number of sites included in the trial;othe length of time and level of marketing required to enroll eligible patients;othe number of doses patients receive; 85——————————————————————————–opotential additional safety monitoring or other trials requested by regulatoryagencies; andothe efficacy and safety profile of the product candidate.We anticipate that we will determine which programs and/or product candidates topursue, if any, as well as the most appropriate funding allocations for eachprogram and/or product candidate, on an ongoing basis in response to theoutcomes of pre-clinical and clinical trials, regulatory developments, and ourongoing assessments of the commercial potential of each program and/or productcandidate.Research and development expenses decreased slightly in 2022 compared to 2021primarily due to the completion of EVOGUARD program in the fourth quarter of2022.

As previously noted, we have discontinued this program and thereforeexpect a significant reduction in clinical trial expense in 2023 versus 2022levels.Selling and Marketing ExpensesOur selling and marketing expenses consist primarily of Phexxi commercializationcosts, including direct to consumer (DTC) and HCP advertising, the Phexxitelehealth platform, our sample program, training, salaries, benefits, travel,noncash stock-based compensation expense, and other related costs for ouremployees and consultants.In connection with our overall cost reduction strategy, our selling and marketing expenses decreased significantly in 2022 compared to 2021 due to reductions in media and marketing activities related to ongoing Phexxi promotional strategies.General and Administrative ExpensesOur general and administrative expenses consist primarily of salaries, benefits,travel, business development expenses, investor and public relations expenses,noncash stock-based compensation, and other related costs for our employees andconsultants performing executive, administrative, finance, legal and humanresource functions. Other general and administrative expenses includefacility-related costs not otherwise included in research and development orselling and marketing, and professional fees for accounting, auditing, tax andlegal fees, and other costs associated with obtaining and maintaining our patentportfolio.Our general and administrative expenses increased in 2022 compared to 2021 primarily due to increased general legal expenses and recruiting and financing related fees.Other Income (Expense)Other income (expense) consists primarily of interest expense and the change infair value of financial instruments issued in various capital raisetransactions. The change in fair value of financial instruments was recognizedas a result of mark-to-market adjustments for those financial instruments.Critical Accounting Policies and Significant Judgments and EstimatesOur consolidated financial statements have been prepared in accordance withgenerally accepted accounting principles (GAAP) in the United States.

Thepreparation of consolidated financial statements requires us to make use ofestimates, assumptions and judgments that affect the reported amounts of assets,expenses, and liabilities, as well as the disclosure of contingent liabilitieson the date of the consolidated financial statements. Management bases itsestimates, assumptions, and judgments on historical experience and on variousother factors it believes to be reasonable under the circumstances. Differentestimates, assumptions and judgments may change the estimate used in thepreparation of our consolidated financial statements, which, in turn, couldmaterially change our results from those reported.

Management evaluates its useof estimates, assumptions, and judgments on an ongoing basis. However, if ourassumptions change, we may need to revise our estimates, or take othercorrective actions, either of which may have a material adverse effect on ourconsolidated statements of operations, liquidity, and financial condition. Webelieve the following critical accounting policies involve significant areaswhere management applies estimates, assumptions, and judgments in thepreparation of our consolidated financial statements.

See Note 2- Summary ofSignificant Accounting Policies .Revenue Recognition and Trade Accounts ReceivableWe recognize revenue from the sale of its product Phexxi in accordance with ASC606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606require the following steps to determine revenue recognition: (1) Identify thecontract(s) with a customer; (2) Identify the performance obligations in thecontract; (3) Determine the transaction price; (4) Allocate the transactionprice to the performance obligations in the contract; (5) Recognize revenue when(or as) the entity satisfies a performance obligation.

86——————————————————————————–In accordance with ASC 606, we recognize revenue when its performance obligationis satisfied by transferring control of the product to a customer. Per ourcontracts with customers, control of the product is transferred upon theconveyance of title, which occurs when the product is sold to and received by acustomer.

Our customers consist of wholesale distributors, retail pharmacies,and a mail-order specialty pharmacy. Payment terms vary by customer, buttypically range from 31 to 66 days and include prompt pay discounts. Tradeaccounts receivable due to us from contracts with its customers are statedseparately in the balance sheet, net of various allowances as described in theTrade Accounts Receivable policy in Note 2- Summary of Significant AccountingPolicies .The amount of revenue we recognize is equal to the amount of consideration whichis expected to be received from the sale of product to its customers.

Revenue isonly recognized when it is probable that a significant reversal will not occurin future periods. To determine the amount of revenue to recognize, we assessboth the likelihood and magnitude of any such potential reversal of revenue.Phexxi is sold to customers at the wholesale acquisition cost. However, we record product revenue, net of estimates for applicable variable consideration.Revenue recognition is subject to uncertainty due to the variable considerationestimates that are required to be made by management.

These estimates includechargebacks, rebates and patient support programs. Management must estimate andaccrue for these amounts primarily by estimating the portion of product in thedistribution supply channel at the reporting date that will be sold through toan entity or end user that will result in a variable consideration expense. Toaccomplish this, management relies on historical sales data showing the amountof various end-user consumer types, inventory reports from the wholesaledistributors and mail-order specialty pharmacy, and other relevant data reports.The recorded variable consideration is directly sensitive to the estimatedinputs made by management that are used in the calculation.

The total balancefor variable considerations was £2.7 million and £2.3 million, as of December31, 2022 and 2021, respectively.Clinical Trial AccrualsAs part of the process of preparing our financial statements, we are required toestimate expenses resulting from our obligations under contracts with vendors,CROs and consultants and under clinical site agreements relating to conductingour clinical trials. The financial terms of these contracts vary and may resultin payment flows that do not match the periods over which materials or servicesare provided under such contracts.Our objective is to reflect the appropriate clinical trial expenses in ourconsolidated financial statements by recording those expenses in the period inwhich services are performed and efforts are expended. We account for theseexpenses according to the progress of the clinical trial as measured by patientprogression and the timing of various aspects of the trial.

We determine accrualestimates through financial models and discussions with applicable personnel andoutside service providers as to the progress of clinical trials.During a clinical trial, we adjust the clinical expense recognition if actualresults differ from estimates. We make estimates of accrued expenses as of eachbalance sheet date based on the facts and circumstances known at that time. Ourclinical trial accruals are partially dependent upon accurate reporting by CROsand other third-party vendors.

Although we do not expect estimates to differmaterially from actual amounts, our understanding of the status and timing ofservices performed relative to the actual status and timing of servicesperformed may vary and may result in reporting amounts that are too high or toolow for any reporting period. For the years ended December 31, 2022 and 2021there were no material adjustments to our prior period estimates of accruedexpenses for clinical trials.Fair Value of the Baker NotesWe elected the fair value option under ASC 825, Financial Instruments, for theBaker Notes issued pursuant to that certain Baker Bros. Purchase Agreement withthe Baker Purchasers, and Baker Bros.

Advisors LP, as designated agent, datedApril 23, 2020, as they are qualified financial instruments and are, in whole,classified as liabilities. Under the fair value option, we recognized the hybriddebt instrument at fair value inclusive of embedded features. Through June 30,2022, the fair value of the Baker Notes issued, and the change in fair value ofthe Baker Notes at the reporting date, were determined using a Monte Carlosimulation-based model.

The Monte Carlo simulation was used to take into accountseveral embedded features and factors, including the future value of our commonstock, a potential change of control event, the probability of meeting certaindebt covenants, the maturity term of the Baker Notes, the probability of anevent of voluntary conversion of the Baker Notes, the probability of the failureto meet the affirmative covenant to achieve £100.0 million in cumulative netsales of Phexxi by June 30, 2023, and the probability of exercise of the putright and the probability of exercise of our call right. The Baker Notes arere-valued as of each reporting date. For the second half of 2022, the fair valueof the Baker Notes was determined by estimating the fair value of the MarketValue of Invested Capital (“MVIC”) of the Company.

This was estimated usingforms of the cost and market approaches. In the Cost approach, an adjusted netasset value method was used to determine the net 87——————————————————————————–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.

If the resulting fair value is not estimated as greater than the contractual payout. the fair value of the Baker Notes then becomes our MVIC available for distribution.The fair value of the Baker Notes was £39.3 million and £81.7 million, as of December 31, 2022 and 2021, respectively.Fair Value of Stock Options and WarrantsUpon the issuance of the options and warrants, they are initially measured atfair value and reviewed for the appropriate classification (liability orequity). Options and warrants determined to require liability accounting aresubsequently re-measured with changes in fair value being recognized as acomponent of other income (expense), net in the consolidated statements ofoperations. Options and warrants are value using an option pricing model basedon the applicable assumptions, which include the exercise price of the warrants,time to expiration, expected volatility of our peer group, risk-free interestrate, and expected dividends.

We re-evaluate the classification of its optionsand warrants at each balance sheet to determine the proper balance sheetclassification for them. The assumptions used in the OPM are considered level 3assumptions and include, but are not limited to, the market value of investedcapital, our cumulative equity value as a proxy for the exercise price, theexpected term the purchase rights will be held prior to exercise and a risk-freeinterest rate, and probability of change of control events.Fair Value of Purchase RightsThe fair value of the rights granted to the Baker Purchasers to optionallypurchase from us up to £10.0 million of Baker Notes, as described in Note 5-Debt at the Baker Purchasers’ discretion at any time prior to us receiving atleast £100.0 million in aggregate gross proceeds from one or more sales ofequity securities issued in connection with the Baker Bros. Purchase Agreement,as described in Note 5- Debt , and the change in fair value of the BakerPurchasers’ option to purchase from us up to £10.0 million of Baker Notes uponexercise of such rights, was determined as the maximum of (i) the fair value ofrights to purchase the additional £10.0 million Baker Notes and (ii) the fairvalue of the shares of on as-if converted basis, which was determined by thelattice model.

Initially, the fair value of purchase rights was valued using aGeske option-pricing model. The Geske model was based on the applicableassumptions, including the underlying stock price, warrant exercise price, theexercise price of the rights to purchase the warrants, the term of the warrants,the term of the rights to purchase the warrants, expected volatility of our peergroup, risk-free interest rate and expected dividends. For the second half of2022, the fair value of the purchase rights were valued using an option pricingmodel (OPM), like a Black-Scholes Merton with changes in the fair value beingrecorded in the consolidated statements of operations.

The assumptions used inthe OPM are considered level 3 assumptions and include, but are not limited to,the market value of invested capital, our cumulative equity value as a proxy forthe exercise price, the expected term the purchase rights will be held prior toexercise and a risk-free interest rate and probability of change of controlevents.InventoriesInventories, consisting of purchased materials, direct labor and manufacturingoverheads, are stated at the lower of cost or net realizable value. Cost isdetermined on a first-in, first-out basis. Net realizable value is the estimatedselling price in the ordinary course of business, less reasonably predictablecosts of completion, disposal, and transportation.

At each balance sheet date,we evaluate ending inventories for excess quantities, obsolescence, orshelf-life expiration. The evaluation includes an analysis of our current andfuture strategic plans, anticipated future sales, the price projections offuture demand, and the remaining shelf life of goods on hand. To the extent thatwe determine there are excess or obsolete inventory or quantities with a shelflife that is too near its expiration for us to reasonably expect that it cansell those products prior to their expiration, we adjust the carrying value toestimated net realizable value in accordance with the first-in, first-outinventory costing method.

88——————————————————————————–Results of OperationsYear Ended December 31, 2022 Compared to Year Ended December 31, 2021 (inthousands):Net Product Sales Year Ended December 31, 2022 vs.

2021 2022 2021 £ Change % ChangeProduct sales, net £ 16,837 8,244 £ 8,593 104%The increase in net product sales was primarily due to continued growth inex-factory Phexxi unit sales and an increase in net sales from the impact ofPhexxi promotional strategies and gross-to-net initiatives implemented in 2022.Cost of Goods Sold Year Ended December 31, 2022 vs.

2021 2022 2021 £ Change % ChangeCost of goods sold £ 4,415 4,055 £ 360 9%The increase in cost of goods sold was primarily due to increase in royalty costs associated with the growth in Phexxi net sales, partially offset by the reversal of excess & obsolete inventory reserve recorded in 2021.Research and Development Expenses Year Ended December 31, 2022 vs.

2021 2022 2021 £ Change % Change Research and development £ 25,032 33,129 £ (8,097) (24)%The decrease in research and development expenses was primarily due to a £7.2million decrease in clinical trial costs associated with EVOGUARD, a £1.1million decrease in payroll and related expenses due to reduced headcount, and a£0.8 million decrease in noncash stock-based compensation. These decreases werepartially offset by a £1.1 million increase in facilities and other research anddevelopment related activities.Selling and Marketing Expenses Year Ended December 31, 2022 vs.

2021 2022 2021 £ Change % ChangeSelling and marketing £ 43,951 113,152 (69,201) (61)%The decrease in selling and marketing expenses was primarily due to a £61.0million decrease in media and marketing costs related to ongoing promotionalstrategies, a £6.3 million decrease in payroll and related expenses due toreduced headcount, £1.6 million in the Phexxi sample program, and a £1.3 milliondecrease in facilities costs. These aggregated decreases were partially offsetby a £2.0 million increase in noncash stock-based compensation.General and Administrative Expenses Year Ended December 31, 2022 vs.

2021 2022 2021 £ Change % ChangeGeneral and administrative £ 27,563 24,709 £ 2,854 12 %The increase in general and administrative expenses was primarily due to a £7.7million increase in legal, corporate, and financing related expenses. Thisincrease was partially offset by a decrease of £3.4 million in noncashstock-based compensation expense and a £1.4 million decrease in payroll relatedexpenses due to reduced headcount.

89——————————————————————————–Total Other Expense, Net Year Ended December 31, 2022 vs.

2021 2022 2021 £ Change % ChangeTotal other expense, net £ 7,470 £ (38,374) £ 45,844 (119) %Total other expense, net, for the year ended December 31, 2022, primarily due togains of: £92.2 million from the change in fair value of the liabilityclassified warrants issued in 2022, and £2.5 million from the partialextinguishment of the Adjuvant Notes, as described in Note 5- Debt . Thesegains were partially offset by losses of: £73.0 million recorded upon issuanceof financial instruments, primarily from the June 2022 Baker Warrants, £10.3million from the change in the fair value of the May Notes as a result ofmark-to-market adjustments and £2.0 million from the change in fair value of theBaker Notes as a result of mark-to-market adjustments unrelated to changes incredit risk, and £2.2 million in interest expense related to the Adjuvant Notes.Total other expense, net, for the year ended December 31, 2021 primarilyincluded £4.7 million in interest expense related to the Baker Notes and theAdjuvant Notes as described in Note 5- Debt and a £33.7 million recordedloss as a result of mark-to-market adjustments including the recorded loss fromthe change in fair value of the Baker Notes and the recorded gain from thechange in fair value of the derivative liabilityLiquidity and Capital ResourcesOverviewAs of December 31, 2022, we had a working capital deficit of £81.1 million andan accumulated deficit of £938.7 million.

We have financed our operations todate primarily through the issuance of preferred stock, common stock andwarrants, cash received from private placement transactions, the issuance ofconvertible notes and, to a lesser extent, product sales. As of December 31,2022, we had approximately £2.8 million in cash and cash equivalents, and £0.9million in restricted cash available for use from the Adjuvant Notes (as definedin Note 5- Debt ). Our cash and cash equivalents include amounts held inchecking accounts.We have incurred losses and negative cash flows from operating activities sinceinception.

During the year ended December 31, 2022, we received gross proceedsof £11.5 million from the sale of notes and warrants in three registered directofferings, net proceeds of £7.4 million from the sale and issuance of commonstock pursuant to the Stock Purchase Agreement, net proceeds of £18.1 millionupon the sale and issuance of common stock and warrants from the May 2022 PublicOffering, and £25.2 million from the exercise of common warrants.We aim to reach operational earnings before interest, taxes, depreciation,amortization (EBITDA) break even on a normalized basis by year-end 2023 andanticipate that we will continue to restructure our trade payables with extendedterms and to attempt to cure existing defaults. We have implemented measures,including headcount reductions in November 2022 and March 2023, to right sizeour cost structure with projected revenues. For 2023, we expect research anddevelopment expenses to decrease significantly primarily due to the completionof EVOGUARD and discontinuation of this clinical program in October 2022;selling and marketing expenses to decrease significantly due to reductions inmedia and marketing activities related to ongoing Phexxi promotional strategies;and general and administrative expenses to decrease slightly due to reductionsin headcount partially offset by increased professional and consulting expenses.Despite the letter of default, our senior lenders have not yet taken additionalactions in accordance with their contractual rights.

If we can cure existingdefaults, we currently expect our liquidity resources as of December 31, 2022,together with the net proceeds from the 2023 Offerings, defined below, costreductions, restructuring of outstanding account payable and liquidity tacticsto be sufficient to fund our planned operations into the third quarter of 2023.We expect, once the 2023 Reverse Stock Split is effectuated, to be back incompliance under the terms of the Baker Notes. As of December 31, 2022, oursignificant commitments include the Baker Notes, as described in Note 5-Debt , our office lease, fleet leases, and our supply and manufacturingagreement with our Phexxi manufacturer, as described in Note 8- Commitmentsand Contingencies . The purpose of these commitments is to further thecommercialization of Phexxi.

We expect to fund these commitments through debtand equity issuances and product sales.Our management is currently evaluating different strategies to obtain therequired funding for our operations. These strategies may include, but are notlimited to: public and private placements of equity and/or debt, licensingand/or collaboration arrangements and strategic alternatives with third parties,corporate restructuring, or other potential funding from third parties. Ourability to secure funding is subject to numerous risks and uncertainties,including the impact of the COVID-19 pandemic, geopolitical turmoil related tothe ongoing hostilities in Ukraine and economic uncertainty related to risinginflation 90——————————————————————————–and disruptions in the global supply chain.

As a result, there can be noassurance that these funding efforts will be successful. Our ability to raiseadditional funds, and the terms on which those funds may be raised, will bedependent, in part, on how successful the commercialization of Phexxi is, thesuccess of our cost reduction and gross-to-net improvement efforts, the accuracyof our estimates regarding cash needed to fund our operations, our ability tocomply with the terms of our debt arrangements, and whether we are able to gainrevenue traction prior to raising additional funds.If we are not able to obtain required additional funding when and as needed,through equity financings or other means, or if we are unable to obtain fundingon terms favorable to us, the shortfall in funds raised, or such unfavorableterms, will likely have a material adverse effect on our operations andstrategic plan for future growth. If we cannot successfully raise the fundingnecessary to implement our current and ongoing liquidity tactics or as necessaryto comply with obligations pursuant to our debt arrangements (including anyacceleration of those obligations), we may be forced to make further reductionsin spending, expand on our extended payment terms with suppliers, liquidateassets where possible, suspend or curtail planned programs, and/or ceaseoperations entirely.

Any of these developments would materially and adverselyaffect our financial condition and business prospects and could even cause us tobe unable to continue as a going concern. If we are unable to continue as agoing concern, we may have to liquidate our assets and, in doing so, we mayreceive less than the value at which those assets are carried on our financialstatements. Any of these developments would materially and adversely affect theprice of our stock and the value of an investment in our stock.

As a result, ourfinancial statements include explanatory disclosures expressing substantialdoubt about our ability to continue as a going concern.The opinion of our independent registered public accounting firm on our auditedfinancial statements as of and for the years ended December 31, 2022 and 2021contains an explanatory paragraph regarding substantial doubt about our abilityto continue as a going concern. Future reports on our financial statements mayinclude an explanatory paragraph with respect to our ability to continue as agoing concern. Our audited consolidated financial statements as of and for theyears ended December 31, 2022 and 2021 included in this Annual Report do notinclude any adjustments relating to the recoverability and classification ofrecorded asset amounts or amounts of liabilities that might be necessary shouldwe be unable to continueour operations.2023 Equity FinancingsIn February, March and April 2023, we entered into securities purchaseagreements with certain investors providing for the sale and issuance of seniorsecured convertible notes (collectively, the 2023 SPAs).

The 2023 SPAs included(i) convertible promissory notes with aggregate original principal amounts ofapproximately £1.4 million, £0.6 million, £0.5 million and £0.8 million,respectively (the 2023 Notes), and (ii) warrants to purchase an aggregate69,230,769, 30,000,000, 26,923,077 and 76,923,077 shares of common stock,respectively (the 2023 Warrants and collectively, the 2023 Offerings). The 2023Offerings closed on February 17, 2023 (the February 2023 Closing), March 13,2023 and March 20, 2023 (the March 2023 Closings) and April 5, 2023 (the April2023 Closing), respectively, with net proceeds to the Company, after deductingoffering expenses, of approximately £0.7 million, £0.3 million, £0.3 million,and £0.5 million, respectively. The 2023 SPAs also included a RegistrationRights Agreement requiring us to register the common stock underlying the 2023Notes and 2023 Warrants within the time frames specified therein.Upon the April 2023 Closing, the conversion and strike prices, as applicable, ofthe Baker Notes, Baker Warrants, the May 2022 Common Warrants, the June 2022Baker Warrants, the Adjuvant Notes, the December 2022 Notes and Warrants, andthe Notes and Warrants in the February and March 2023 Closing reset to £0.0065per share, accordingly.

Additionally, the Company’s outstanding Purchase Rightsincreased by approximately 3.1 billion since December 31, 2022.2022 Debt and Equity FinancingsAs described in Note 5- Debt , we received net proceeds of £10.0 million,before issuance costs, from the sale of notes and warrants in two registereddirect offerings in the first quarter of 2022. These notes were then exchangedfor the May 2022 Notes during the May 2022 Exchange transaction, as defined in Note 5- Debt , which were subsequently exchanged for Purchase Rights duringthe debt restructuring in September 2022 with a total outstanding balance of£21.8 million immediately prior to the restructuring.As described in Note 10 – Stockholders’ Equity (Deficit) , we received netproceeds of £18.1 million upon the sale and issuance of common stock andwarrants from an underwritten public offering in May 2022, net proceeds of£7.4 million from the sale and issuance of common stock pursuant to the StockPurchase Agreement, and £25.2 million from the exercise of common warrants.As described in Note 5- Debt , we received gross proceeds of £2.3 million, before issuance costs, from the sale of notes, warrants and non-convertible Series D preferred stock in the December 2022. 91——————————————————————————–2021 Equity FinancingsAs described in Note 10- Stockholders’ Equity (Deficit) , we receivedproceeds of approximately £28.0 million, net of underwriting discounts, from apublic offering in March 2021, upon the issuance of 1,142,857 shares of ourcommon stock, and approximately £4.2 million, net of underwriting discounts,from the issuance of 171,428 shares of common stock upon exercise of theunderwriters’ overallotment option in April 2021.As described in Note 10- Stockholders’ Equity (Deficit) , we receivedproceeds of approximately £46.8 million, net of underwriting discounts and fees,from a public offering in May 2021, upon the issuance of 3,333,333 shares ofcommon stock and common warrants to purchase 3,333,333 shares of common stock.We received approximately £2.4 million and £0.1 million, both net ofunderwriting discounts, from the issuance of 169,852 shares of common stock and500,000 common warrants, respectively, upon exercise of the underwriter’soverallotment option in May 2021.As described in Note 10- Stockholders’ Equity (Deficit) , we received proceeds of approximately £9.6 million, net of offering expenses, from a registered direct offering in October 2021, upon the issuance of 5,000 shares of Series B-1 Convertible Preferred Stock and 5,000 shares of Series B-2 Convertible Preferred Stock.Summary Statements of Cash FlowsThe following table sets forth a summary of the net cash flow activity for the years ended December 31, 2022 and 2021 (in thousands): Year Ended December 31, 2022 vs.

2021 2022 2021 £ Change % ChangeNet cash, cash equivalents and restricted cash used in operating activities £ (70,410) £ (146,667) £ 76,257 (52) % Net cash, cash equivalents and restricted cash used in investing activities (341) (2,689) 2,348 (87) %Net cash, cash equivalents and restricted cash provided by financing activities 61,939 90,693 (28,754) (32) %Net (decrease) increase in cash, cash equivalents andrestricted cash £ (8,812) £ (58,663) £ 49,851 (85) %Cash Flows from Operating Activities. During the years ended December 31, 2022and 2021, the primary use of cash, cash equivalents and restricted cash was tofund commercialization of our lead product Phexxi, to fund the Phase 3 clinicaltrial to evaluate EVO100 for the prevention of chlamydia and gonorrhea, and tosupport selling and marketing and general and administrative operations.Cash Flows from Investing Activities.

During the year ended December 31, 2022,the change in net cash, cash equivalents and restricted cash used in investingactivities was primarily due to £0.3 million in purchases of property andequipment. During the year ended December 31, 2021, the change in net cash, cashequivalents and restricted cash used in investing activities was primarily dueto £2.9 million in purchases of property and equipment, offset by a £0.3 millioncash inflow from the sale of Softcup line of business.Cash Flows from Financing Activities. During the year ended December 31, 2022,the primary source of cash, cash equivalents and restricted cash was providedfrom the issuance of 22,665,000 shares of common stock, warrants to purchase71,000,000 shares of common stock and pre-funded warrants to purchase 12,835,000shares of common stock for net proceeds of £24.9 million; the issuance of35,314,846 shares of our common stock for net proceeds of £25.2 million from theexercise of common warrants; and the issuance of 1,964,272 shares of commonstock for net proceeds of £7.4 million and net proceeds of £11.5 million fromthe sale of term notes and warrants, net of original issue discount whenapplicable.During the year ended December 31, 2021, the primary source of cash, cashequivalents and restricted cash was provided from the issuance of 4,817,470shares of common stock and 500,000 shares of common warrants for proceeds ofapproximately £81.5 million, net of underwriting discounts, the issuance of30,708 shares of our common stock under the 2019 Employee Stock Purchase Plan(ESPP) with proceeds of approximately £0.3 million, the issuance of 10,599shares of common stock from the exercise of common warrants for proceeds ofapproximately £0.2 million, the issuance of 5,000 shares of Series B-1Convertible Preferred Stock and 5,000 shares of Series B-2 Convertible PreferredStock for proceeds of approximately £9.6 million, net of offering expenses,offset by £0.3 million in payments of tax withholdings related to vesting ofrestricted stock awards and £1.0 million in payments for financing issuancecosts.

92——————————————————————————–Operating and Capital Expenditure RequirementsOur specific future operating and capital expense requirements are difficult toforecast. However, we can anticipate the general types of expenses and areas inwhich they might occur in 2023 as follows: we expect research and developmentexpenses to decrease significantly due to the completion of the EVOGUARD trialand discontinuation of the program developing EVO100; selling and marketingexpenses to decrease significantly; and general and administrative expenses toincrease slightly due to the reasons stated under the Operating Expenses sectionabove.Contractual Obligations and CommitmentsOperating LeasesOn December 31, 2022, operating lease ROU assets and lease liabilities were£4.4 million and £5.4 million, respectively, and were £5.4 million and£6.8 million, respectively, on December 31, 2021. See Note 8- Commitments andContingencies for more detailed discussions on leases and financial statementsinformation under ASC 842, Leases.Other Contractual CommitmentsAs described in Note 8- Commitments and Contingencies , in November 2019, theCompany entered into a supply and manufacturing agreement with a third-party tomanufacture Phexxi, with potential to manufacture other product candidates inaccordance with all applicable current good manufacturing practice regulations,pursuant to which the Company has certain minimum purchase commitments based onthe forecasted product sales.

The amounts purchased under the supply andmanufacturing agreement were £1.0 million and £3.0 million for the years endedDecember 31, 2022 and 2021, respectively.Intellectual Property RightsAs described in Note 8- Commitments and Contingencies , royalty costs owed toRush University pursuant to the Rush License Agreement were £1.1 million and£0.2 million for the years ended December 31, 2022 and 2021, respectively.

As ofDecember 31, 2022 and 2021, approximately £0.6 million and £31,000 were includedin accrued expenses in the consolidated balance sheets.

93——————————————————————————–(C) Edgar Online, source Glimpses