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Last10K.com | 10-K Annual Report Thu Mar 07 2019
Exhibit 99.1
AcelRx Pharmaceuticals Announces Commercial Launch of DSUVIA and Reports Fourth Quarter and Full Year 2018 Financial Results
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DSUVIA now available for use in certified medically supervised healthcare settings, with initial shipments to wholesalers completed in the second half of February 2019 |
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Executed contracts with Group Purchasing Organizations (GPOs) covering approximately 80% of commercial launch targets |
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Cash, cash equivalents and short-term investments of $105.7 million as of December 31, 2018 |
REDWOOD CITY, Calif., March 7, 2019 – AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today provided a business update and reported its fourth quarter and full year 2018 financial results.
“This past year was a tremendous success for the Company, highlighted by the FDA approval of DSUVIA in the U.S., followed by our staged launch last month,” said Vince Angotti, Chief Executive Officer of AcelRx. “Our recent efforts with the wholesalers and GPOs have laid the foundation for DSUVIA’s use in certified medically supervised healthcare settings. While the launch is only one month old, we are pleased with the initial response by healthcare professionals to DSUVIA as an effective and efficient new option for the management of acute pain in these settings,” continued Angotti.
Fourth Quarter and Recent Highlights
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Following the positive recommendation from the FDA advisory committee in October 2018, the FDA approved DSUVIA in November 2018 for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. |
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AcelRx now has 14 Orange Book listed patents with exclusivity dates ranging from 2027 through 2031. |
The following information was filed by Acelrx Pharmaceuticals Inc (ACRX) on Thursday, March 7, 2019 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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Acelrx Pharmaceuticals Inc's Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:
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Revenue - Product Highlight
In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation.
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Other - Other Highlight
A critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations.
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Other - Other Highlight
Specifically, critical accounting estimates have the following attributes: (i) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and (ii) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.
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Financial - Cash Flow Highlight
We have incurred net losses and generated negative cash flows from operations since inception and expect to incur losses in the future as we begin commercialization activities to support the U.S. launch of DSUVIA, continue our research and development activities and support Grunenthals European sales of Zalviso.
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Financial - Cash Flow Highlight
As a result, we expect to continue to incur operating losses and negative cash flows until such time as DSUVIA has gained market acceptance and generated significant revenues.
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Financial Statements, Disclosures and Schedules
Inside this 10-K Annual Report
Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parentheticals)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Comprehensive Loss
Consolidated Statements Of Stockholders' Equity (Deficit)
Note 1 - Organization And Summary Of Significant Accounting Policies
Note 1 - Organization And Summary Of Significant Accounting Policies (Details Textual)
Note 10 - Warrants
Note 10 - Warrants (Details Textual)
Note 11 - Commitments And Contingencies
Note 11 - Commitments And Contingencies (Details Textual)
Note 11 - Commitments And Contingencies (Tables)
Note 11 - Commitments And Contingencies - Future Minimum Payments Under Lease Agreement (Details)
Note 12 - Stockholders' Equity
Note 12 - Stockholders' Equity (Details Textual)
Note 13 - Stock-Based Compensation
Note 13 - Stock-Based Compensation (Details Textual)
Note 13 - Stock-Based Compensation (Tables)
Note 13 - Stock-Based Compensation - Assumptions To Calculate Fair Value Of Each Employee Stock Option (Details)
Note 13 - Stock-Based Compensation - Option Activity (Details)
Note 13 - Stock-Based Compensation - Stock Options Outstanding, Vested And Exercisable (Details)
Note 13 - Stock-Based Compensation - Stock-Based Compensation Expense (Details)
Note 14 - Net Loss Per Share Of Common Stock
Note 14 - Net Loss Per Share Of Common Stock (Tables)
Note 14 - Net Loss Per Share Of Common Stock - Common Stock Excluded From Computation Of Diluted Net Loss Per Share (Details)
Note 15 - Accrued Liabilities
Note 15 - Accrued Liabilities (Tables)
Note 15 - Accrued Liabilities - Accrued Liabilities (Details)
Note 16 - 401(K) Plan
Note 16 - 401(K) Plan (Details Textual)
Note 17 - Income Taxes
Note 17 - Income Taxes (Details Textual)
Note 17 - Income Taxes (Tables)
Note 17 - Income Taxes - Net Deferred Tax Assets (Details)
Note 17 - Income Taxes - Provision (Benefit) For Income Taxes (Details)
Note 17 - Income Taxes - Reconciliation Of Beginning And Ending Balance Of Unrecognized Tax Benefits (Details)
Note 17 - Income Taxes - Reconciliation Of Statutory Federal Income Tax (Details)
Note 18 - Subsequent Event
Note 18 - Subsequent Event (Details Textual)
Note 19 - Unaudited Quarterly Financial Data
Note 19 - Unaudited Quarterly Financial Data (Tables)
Note 19 - Unaudited Quarterly Financial Data - Quarterly Financial Data (Details)
Note 2 - Investments And Fair Value Measurement
Note 2 - Investments And Fair Value Measurement (Details Textual)
Note 2 - Investments And Fair Value Measurement (Tables)
Note 2 - Investments And Fair Value Measurement - Fair Value Of Financial Assets And Liabilities By Level Within Fair Value Hierarchy (Details)
Note 2 - Investments And Fair Value Measurement - Summary Of Cash, Cash Equivalents And Investments (Details)
Note 2 - Investments And Fair Value Measurement - Summary Of Changes In Fair Value Of Level Iii Financial Liabilities (Details)
Note 3 - Inventories
Note 3 - Inventories (Details Textual)
Note 3 - Inventories (Tables)
Note 3 - Inventories - Inventory Components (Details)
Note 4 - Property And Equipment
Note 4 - Property And Equipment (Details Textual)
Note 4 - Property And Equipment (Tables)
Note 4 - Property And Equipment - Components Of Property And Equipment (Details)
Note 5 - Adoption Of Asc Topic 606, Revenue From Contracts With Customers
Note 5 - Adoption Of Asc Topic 606, Revenue From Contracts With Customers (Details Textual)
Note 5 - Adoption Of Asc Topic 606, Revenue From Contracts With Customers (Tables)
Note 5 - Adoption Of Asc Topic 606, Revenue From Contracts With Customers - Changes In Contract Liabilities (Details)
Note 5 - Adoption Of Asc Topic 606, Revenue From Contracts With Customers - Disaggregation Of Revenue (Details)
Note 6 - U.S. Department Of Defense Funding
Note 6 - U.S. Department Of Defense Funding (Details Textual)
Note 7 - Collaboration Agreement
Note 7 - Collaboration Agreement (Details Textual)
Note 7 - Collaboration Agreement (Tables)
Note 7 - Collaboration Agreement - Summary Of Revenue Recognized Under The Amended Agreements (Details)
Note 8 - Long-Term Debt
Note 8 - Long-Term Debt (Details Textual)
Note 8 - Long-Term Debt (Tables)
Note 8 - Long-Term Debt - Outstanding Future Payments Of Long-Term Debt (Details)
Note 9 - Liability Related To Sale Of Future Royalties
Note 9 - Liability Related To Sale Of Future Royalties (Details Textual)
Note 9 - Liability Related To Sale Of Future Royalties (Tables)
Note 9 - Liability Related To Sale Of Future Royalties - Activity Of Liability Related To Sale Of Future Royalties (Details)
Reconciliation Of Cash, Cash Equivalents, And Restricted Cash
Reconciliation Of Cash, Cash Equivalents, And Restricted Cash (Tables)
Reconciliation Of Cash, Cash Equivalents, And Restricted Cash - Schedule Of Cash, Cash Equivalents, And Restricted Cash (Details)
Significant Accounting Policies (Policies)
Material Contracts, Statements, Certifications & more
Acelrx Pharmaceuticals Inc provided additional information to their SEC Filing as exhibits
Exhibit 10.18: Material Contract
Exhibit 10.44: Material Contract
Exhibit 21.2: Subsidaries Of The Registrant
Exhibit 23.1: Consents Of Experts And Counsel
Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification
Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification
Exhibit 32.1: Section 1350 Certification
Ticker: ACRX
CIK: 1427925
Form Type: 10-K Annual Report
Accession Number: 0001437749-19-004353
Submitted to the SEC: Thu Mar 07 2019 12:25:24 PM EST
Accepted by the SEC: Thu Mar 07 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations
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