Evofem Biosciences, Inc. (EVFM) SEC Filing 10-Q Quarterly report for the period ending Tuesday, March 31, 2020

SEC Filings

ALNY Quarterly Reports

Alnylam Pharmaceuticals, Inc.

CIK: 1618835 Ticker: ALNY

Exhibit 99.1

 Evofem Biosciences Reports First Quarter 2020 Financial Results
and Provides Corporate Update
- On-Track for Phexxi™ PDUFA Date: May 25, 2020 -
- End-of-Phase 2 Meeting with FDA Today to Review Results of the AMPREVENCE Trial -
- Management to Host Conference Call Wednesday, May 6, 2020 at 11:00 a.m. EDT -

San Diego, May 6, 2020 - Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today reported financial results for the three-month period ended March 31, 2020.

"We are now less than three weeks away from the PDUFA date for Phexxi™ and the potential to deliver the first non-hormonal contraceptive innovation in decades. We are encouraged by our ongoing discussions with the FDA regarding the potential label for Phexxi and we look forward to sharing more details about our unique Phexxi TeleContraception™ platform and other launch initiatives on today’s call," said Saundra Pelletier, Evofem’s Chief Executive Officer.

"Our recent strategic financing agreement for up to $25 million, coupled with our disciplined approach to resource allocation, gives us the financial flexibility we need to ensure that Phexxi gets the launch it deserves. If approved, we plan to launch Phexxi in early September along with a robust offering of support services designed to facilitate access to Phexxi and establish Evofem as a leader in women's health."

Recent highlights:
Entered into discussions with the U.S. Food and Drug Administration (FDA) regarding the proposed label for Phexxi™ (L-lactic acid, citric acid, potassium bitartrate), the Company’s investigational Multipurpose Vaginal pH Regulator (MVP-R™) for the prevention of pregnancy. The Prescription Drug User Fee Act (PDUFA) target action date for the completion of the FDA’s review of the New Drug Application (NDA) for Phexxi is May 25, 2020. 
After careful consideration of the impact of COVID-19 on all aspects of the healthcare landscape, notably restrictions on physician interactions, the Company made a strategic decision to push the planned Phexxi commercial launch to the first week of September.
End-of-phase 2 meeting to be held today with the FDA scheduled for today to discuss the AMPREVENCE study results, and determine the clinical and regulatory path forward for EVO100, the Company’s investigational MVP-R candidate for the prevention of urogenital chlamydia and gonorrhea in women.
Secured funding up to $25 million in strategic interim financing, with $15 million initially funded at close.
Three new data sets from the Phase 3 AMPOWER trial of Phexxi for prevention of pregnancy accepted for poster presentations at the 2020 American College of Obstetricians and Gynecologists (ACOG) annual meeting and published in Obstetrics & Gynecology (The Green Journal) (May 2020, Vol 135).

First Quarter Financial Results
For the three months ended March 31, 2020, total operating expenses increased 41% to $19.2 million. The increase was almost entirely associated with pre-commercialization efforts related to the potential U.S. launch of Phexxi for hormone-free, woman-controlled, on-demand contraception.

The following information was filed by Alnylam Pharmaceuticals, Inc. (ALNY) on Wednesday, May 6, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Operations (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity (Deficit) (Unaudited)
Balance Sheet Details
Balance Sheet Details (Tables)
Balance Sheet Details - Accrued Expenses (Details)
Balance Sheet Details - Other Non Current Assets (Details)
Balance Sheet Details - Prepaid And Other Current Assets (Details)
Balance Sheet Details - Property And Equipment, Net (Details)
Balance Sheet Details - Short-Term Investments (Details)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Details)
Commitments And Contingencies - Future Operating Lease Maturities (Details)
Commitments And Contingencies - Supplemental Cash Flow Information (Details)
Commitments And Contingencies - Supplemental Financial Statement Information (Details)
Description Of Business And Basis Of Presentation
Description Of Business And Basis Of Presentation - Additional Information (Details)
Fair Value Of Financial Instruments
Fair Value Of Financial Instruments (Tables)
Fair Value Of Financial Instruments - Fair Values Of Assets Measured On A Recurring Basis (Details)
Private Placement
Private Placement - Additional Information (Details)
Related-Party Transactions
Related-Party Transactions (Tables)
Related-Party Transactions - Additional Information (Details)
Related-Party Transactions - Summary Of Receivables, Payables, Payments And Expenses Of Company's Transactions (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Summary Of Assumptions (Details)
Stock-Based Compensation - Summary Of Stock-Based Compensation Expense Related To Stock Options, Restricted Stock Awards (Rsas) And Rsus Granted To Employees And Non-Employee Directors (Details)
Stockholders' Equity
Stockholders' Equity (Tables)
Stockholders' Equity - Additional Information (Details)
Stockholders' Equity - Summary Of Common Stock Reserved For Future Issuance (Details)
Stockholders' Equity - Summary Of Warrants (Details)
Subsequent Events
Subsequent Events (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Schedule Of Reconciliation Of Cash, Cash Equivalents And Restricted Cash (Details)
Summary Of Significant Accounting Policies - Summary Of Potentially Dilutive Securities Excluded From Calculation Of Diluted Net Loss Per Share (Details)

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Alnylam Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits

Ticker: ALNY
CIK: 1178670
Form Type: 10-Q Quarterly Report
Accession Number: 0001618835-20-000105
Submitted to the SEC: Wed May 06 2020 8:11:04 AM EST
Accepted by the SEC: Wed May 06 2020
Period: Tuesday, March 31, 2020
Industry: Pharmaceutical Preparations

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