UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
| | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. |
For the quarterly period ended
or
| | TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. |
For the transition period from to
Commission File Number:
ACELRX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| | |
| (State or other jurisdiction of | (IRS Employer |
(
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class: | Trading symbol(s) | Name of Each Exchange on Which registered: |
| | | The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:
| Large accelerated filer | ☐ | Accelerated filer | |
| | ☒ | Smaller reporting company | |
| Emerging growth company | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2) Yes
As of August 11, 2021, the number of outstanding shares of the registrant’s common stock was
ACELRX PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED JUNE 30, 2021
TABLE OF CONTENTS
| Page |
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| PART I. FINANCIAL INFORMATION |
5 | |
| Item 1. |
Financial Statements |
5 |
| Condensed Consolidated Balance Sheets as of June 30, 2021 (unaudited) and December 31, 2020 |
5 | |
| Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2021 and 2020 (unaudited) |
6 | |
| Condensed Consolidated Statements of Stockholders’ (Deficit) Equity for the three and six months ended June 30, 2021 and 2020 (unaudited) |
7 | |
| Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2021 and 2020 (unaudited) |
8 | |
| Notes to Condensed Consolidated Financial Statements (unaudited) |
9 | |
| Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
21 |
| Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
30 |
| Item 4. |
Controls and Procedures |
30 |
| PART II. OTHER INFORMATION |
30 | |
| Item 1. |
Legal Proceedings |
30 |
| Item 1A. |
Risk Factors |
31 |
| Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
63 |
| Item 3. |
Defaults Upon Senior Securities |
63 |
| Item 4. |
Mine Safety Disclosures |
63 |
| Item 5. |
Other Information |
63 |
| Item 6. |
Exhibits |
64 |
Unless the context indicates otherwise, the terms “AcelRx,” “AcelRx Pharmaceuticals,” “we,” “us” and “our” refer to AcelRx Pharmaceuticals, Inc., and its consolidated subsidiaries. “DZUVEO” is a trademark, and “ACELRX”, “DSUVIA” and “Zalviso” are registered trademarks, all owned by AcelRx Pharmaceuticals, Inc. This report also contains trademarks and trade names that are the property of their respective owners.
Forward-Looking Statements
This Quarterly Report on Form 10-Q, or Form 10-Q, contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by that section. The forward-looking statements in this Form 10-Q are contained principally under “Part I. Financial Information - Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Part II. Other Information - Item 1A. Risk Factors”. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Many important factors affect our ability to achieve our objectives, including:
| • |
the accuracy of our estimates regarding the sufficiency of our cash resources, future revenues, expenses, capital requirements and needs for additional financing, and our ability to obtain additional financing; |
| • |
the uncertainties and impact arising from the worldwide COVID-19 pandemic, including restrictions on the ability of our sales force to contact and communicate with target customers and resulting delays and challenges to our commercial sales of DSUVIA® (sufentanil sublingual tablet, 30 mcg); |
| • |
our success in commercializing DSUVIA in the United States, including the marketing, sales, and distribution of the product, whether alone or with contract sales organizations and other collaborators; |
| • |
our ability to satisfactorily comply with FDA regulations concerning the advertising and promotion of DSUVIA, including receiving a close out letter resolving the concerns raised by FDA in the warning letter delivered to us on February 11, 2021; |
| • |
the size and growth potential of the markets for DSUVIA, and Zalviso® (sufentanil sublingual tablet system), if approved in the United States, and our ability to serve those markets; |
| • |
our ability to maintain regulatory approval of DSUVIA in the United States, including effective management of and compliance with the DSUVIA Risk Evaluation and Mitigation Strategies, or REMS, program; |
| • |
acceptance of DSUVIA by physicians, patients and the healthcare community, including the acceptance of pricing and placement of DSUVIA on payers’ formularies; |
| • |
the integration and performance of any assets or businesses we acquire; |
| • |
our ability to develop and commercialize products and product candidates that we in-license; |
| • |
our ability to develop sales and marketing capabilities in a timely fashion, whether alone through recruiting qualified employees, by engaging a contract sales organization, or with potential future collaborators; |
| • |
successfully establishing and maintaining commercial manufacturing with third parties; |
| • |
our ability to manage effectively, and the impact of any costs associated with, potential governmental investigations, inquiries, regulatory actions or lawsuits that may be brought against us; |
| • |
continued demonstration of an acceptable safety profile of DSUVIA; |
| • |
effectively competing with other medications for the treatment of moderate-to-severe acute pain in medically supervised settings, including IV-opioids and any subsequently approved products; |
| • |
our ability to manufacture and supply DZUVEO® to Laboratoire Aguettant, or Aguettant, in accordance with their forecasts and the License and Commercialization Agreement, or DZUVEO Agreement, with Aguettant; |
| • |
the status of the DZUVEO Agreement or any other future potential collaborations, including potential milestones and revenue share payments under the DZUVEO Agreement; |
| • |
our, or Aguettant’s, ability to maintain regulatory approval of DZUVEO in the European Union, or EU; |
| • |
our ability to timely and efficiently close-out our relationship with Grünenthal GmbH, or Grünenthal, following the termination of our Collaboration and License Agreement and the Manufacture and Supply Agreement; |
| • |
our ability to fulfill our obligations under the Purchase and Sale Agreement with SWK Funding, LLC, or SWK, (assignee of PDL BioPharma, Inc., or PDL) including our obligation to use commercially reasonable efforts to negotiate a replacement license agreement for Zalviso with a third party; |
| • |
our ability to successfully execute the pathway towards a resubmission of the Zalviso New Drug Application, or NDA, and subsequently obtain and maintain regulatory approval of Zalviso in the United States and comply with any related restrictions, limitations, and/or warnings in the label of Zalviso, if approved; |
| • |
the outcome of any potential FDA Advisory Committee meeting held for Zalviso; |
| • |
our ability to successfully commercialize Zalviso, if approved in the United States; |
| • |
the rate and degree of market acceptance of Zalviso, if approved in the United States; |
| • |
our ability to obtain adequate government or third-party payer reimbursement; |
| • |
our ability to attract additional collaborators with development, regulatory and commercialization expertise; |
| • |
our ability to successfully retain our key commercial, scientific, engineering, medical or management personnel and hire new personnel as needed; |
| • |
regulatory developments in the United States and foreign countries; |
| • |
the performance of our third-party suppliers and manufacturers, including any supply chain impacts or work limitations resulting from shelter-in-place orders related to COVID-19; |
| • |
the success of competing therapies that are or become available; |
| • |
our liquidity and capital resources; and |
| • |
our ability to obtain and maintain intellectual property protection for DSUVIA/DZUVEO and Zalviso. |
In addition, you should refer to “Part II. Other Information - Item 1A. Risk Factors” in this Form 10-Q for a discussion of these and other important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Form 10-Q will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Also, forward-looking statements represent our estimates and assumptions only as of the date of this Form 10-Q. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
AcelRx Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share data)
| June 30, 2021 (unaudited) | December 31, 2020(1) | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Short-term investments | ||||||||
| Accounts receivable, net | ||||||||
| Inventories, net | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Operating lease right-of-use assets | ||||||||
| Property and equipment, net | ||||||||
| Other assets | ||||||||
| Total Assets | $ | $ | ||||||
| Liabilities and Stockholders’ Deficit | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued and other liabilities | ||||||||
| Long-term debt, current portion | ||||||||
| Operating lease liabilities, current portion | ||||||||
| Total current liabilities | ||||||||
| Long-term debt, net of current portion | ||||||||
| Operating lease liabilities, net of current portion | ||||||||
| Liability related to the sale of future royalties, net of current portion | ||||||||
| Other long-term liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and Contingencies | ||||||||
| Stockholders’ Deficit: | ||||||||
| Common stock, par value— shares authorized as of June 30, 2021 and December 31, 2020; and shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ deficit | ( | ) | ( | ) | ||||
| Total Liabilities and Stockholders’ Deficit | $ | $ | ||||||
| (1) |
The condensed consolidated balance sheet as of December 31, 2020 has been derived from the audited financial statements as of that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. |
See notes to condensed consolidated financial statements.
AcelRx Pharmaceuticals, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited)
(In thousands, except share and per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
|
2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||
| Contract and other collaboration | ||||||||||||||||
| Total revenue | ||||||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of goods sold | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling, general and administrative | ||||||||||||||||
| Total operating costs and expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest income and other (expense) income, net | ( | ) | ||||||||||||||
| Non-cash interest income on liability related to future sale of royalties | ||||||||||||||||
| Total other income | ||||||||||||||||
| Net loss before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Provision for income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share of common stock, basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Shares used in computing net loss per share of common stock, basic and diluted – See Note 11 | ||||||||||||||||
See notes to condensed consolidated financial statements.
AcelRx Pharmaceuticals, Inc.
Condensed Consolidated Statements of Stockholders’ (Deficit) Equity
(Unaudited)
(in thousands, except share data)
| Common Stock | Additional Paid-in Capital | Accumulated | Total (Deficit) | |||||||||||||||||
| Shares | Amount | |||||||||||||||||||
| Balance as of December 31, 2020 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Stock-based compensation | — | — | — | |||||||||||||||||
| Restricted stock units vested | — | — | — | — | ||||||||||||||||
| Tax payments related to shares withheld for restricted stock units vested | — | — | ( | ) | — | ( | ) | |||||||||||||
| Net proceeds from issuance of common stock in connection with equity financings | — | |||||||||||||||||||
| Issuance of common stock upon ESPP purchase | — | — | ||||||||||||||||||
| Issuance of common stock upon exercise of stock options | — | — | ||||||||||||||||||
| Net loss | — | — | — | ( | ) | ( | ) | |||||||||||||
| Balance as of March 31, 2021 | ( | ) | ( | ) | ||||||||||||||||
| Stock-based compensation | — | — | — | |||||||||||||||||
| Restricted stock units vested | — | — | — | — | ||||||||||||||||
| Issuance of common stock upon exercise of stock options | — | |||||||||||||||||||
| Net loss | — | — | — | ( | ) | ( | ) | |||||||||||||
| Balance as of June 30, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Common Stock | Additional Paid-in Capital | Accumulated | Total (Deficit) | |||||||||||||||||
| Shares | Amount | |||||||||||||||||||
| Balance as of December 31, 2019 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Stock-based compensation | — | — | — | |||||||||||||||||
| Restricted stock units vested | — | — | — | — | ||||||||||||||||
| Tax payments related to shares withheld for restricted stock units vested | — | — | ( | ) | — | ( | ) | |||||||||||||
| Net proceeds from issuance of common stock in connection with equity financings | — | |||||||||||||||||||
| Issuance of common stock upon ESPP purchase | — | — | ||||||||||||||||||
| Net loss | — | — | — | ( | ) | ( | ) | |||||||||||||
| Balance as of March 31, 2020 | ( | ) | ( | ) | ||||||||||||||||
| Stock-based compensation | — | — | — | |||||||||||||||||
| Restricted stock units vested | — | — | — | — | ||||||||||||||||
| Net proceeds from issuance of common stock in connection with equity financings | — | — | ||||||||||||||||||
| Net loss | — | — | — | ( | ) | ( | ) | |||||||||||||
| Balance as of June 30, 2020 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
See notes to condensed consolidated financial statements.
AcelRx Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
| Six Months | ||||||||
| 2021 | 2020 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Non-cash royalty revenue related to royalty monetization | ( | ) | ( | ) | ||||
| Non-cash interest income on liability related to royalty monetization | ( | ) | ( | ) | ||||
| Depreciation and amortization | ||||||||
| Non-cash interest expense related to debt financing | ||||||||
| Stock-based compensation | ||||||||
| Other | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ||||||||
| Inventories | ||||||||
| Prepaid expenses and other assets | ( | ) | ||||||
| Accounts payable | ( | ) | ||||||
| Accrued liabilities | ( | ) | ( | ) | ||||
| Operating lease liabilities | ( | ) | ( | ) | ||||
| Deferred revenue | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ||||
| Purchase of investments | ( | ) | ( | ) | ||||
| Proceeds from maturities of investments | ||||||||
| Net cash (used in) provided by investing activities | ( | ) | ||||||
| Cash flows from financing activities: | ||||||||
| Payment of long-term debt | ( | ) | ||||||
| Net proceeds from issuance of common stock in connection with equity financings | ||||||||
| Net proceeds from issuance of common stock through equity plans | ||||||||
| Payment of employee tax obligations related to vesting of restricted stock units | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| Net (decrease) increase in cash and cash equivalents | ( | ) | ||||||
| Cash and cash equivalents—Beginning of period | ||||||||
| Cash and cash equivalents—End of period | $ | $ | ||||||
See notes to condensed consolidated financial statements.
AcelRx Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except where otherwise noted)
1. Organization and Summary of Significant Accounting Policies
The Company
AcelRx Pharmaceuticals, Inc., or the Company or AcelRx, was incorporated in Delaware on July 13, 2005 as SuRx, Inc., and in January 2006, the Company changed its name to AcelRx Pharmaceuticals, Inc. The Company’s operations are based in Hayward, California.
AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. DSUVIA® (known as DZUVEO® in Europe) and Zalviso® are both focused on the treatment of acute pain, and each utilize sufentanil, delivered via a non-invasive route of sublingual administration, exclusively for use in medically supervised settings. On November 2, 2018, the U.S. Food and Drug Administration, or FDA, approved DSUVIA for use in adults in a certified medically supervised healthcare setting, 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. The commercial launch of DSUVIA in the United States occurred in the first quarter of 2019. In June 2018, the European Commission, or EC, granted marketing approval of DZUVEO for the management of acute moderate to severe pain in adults in medically monitored settings. AcelRx is further developing a distribution capability and commercial organization to continue to market and sell DSUVIA in the United States. In geographies where AcelRx decides not to commercialize products by itself, the Company may seek to out-license commercialization rights. The Company currently intends to commercialize and promote DSUVIA/DZUVEO outside the United States with one or more strategic partners, and, in July 2021, entered into a License and Commercialization Agreement with Laboratoire Aguettant, or Aguettant, for Aguettant to commercialize DZUVEO in the European Union, Norway, Iceland, Liechtenstein, Andorra, Vatican City, Monaco, Switzerland and the United Kingdom (see Note 12 “Subsequent Events” below). The timing of the resubmission of the Zalviso new drug application, or NDA, is in part dependent upon the finalization of the FDA’s new opioid approval guidelines and process. AcelRx intends to seek regulatory approval for Zalviso in the United States and, if successful, potentially promote Zalviso either by itself or with strategic partners. Zalviso is approved in Europe and was commercialized by Grünenthal GmbH, or Grünenthal, through May 12, 2021 (see Termination of Grünenthal Agreements below). In July 2021, the Company also entered into a separate License and Commercialization Agreement with Aguettant pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe containing 10 ml of a solution of 3 mg/ml ephedrine hydrochloride for injection, and (ii) a phenylephrine prefilled syringe containing 10 ml of a solution of 50 mcg/ml phenylephrine hydrochloride for injection (see Note 12 “Subsequent Events” below).
The Company has incurred recurring operating losses and negative cash flows from operating activities since inception. As of June 30, 2021 and December 31, 2020, the Company had cash, cash equivalents and short-term investments of $
DSUVIA/DZUVEO
DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018 and granted marketing approval by the EC in June 2018, is indicated for use in adults in a certified medically supervised healthcare setting, 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. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with IV administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator, or SDA, by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous, or IV, and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration.
DSUVIA was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which restricts distribution to certified medically supervised healthcare settings in order to prevent respiratory depression resulting from accidental exposure. DSUVIA is only distributed to facilities certified in the DSUVIA REMS program following attestation by an authorized representative to comply with appropriate dispensing and use restrictions of DSUVIA. To become certified, a healthcare setting is required to train their healthcare professionals on the proper use of DSUVIA and have the ability to manage respiratory depression. DSUVIA is not available in retail pharmacies or for outpatient use. As part of the REMS program, the Company monitors distribution and audits wholesalers’ data, evaluates proper usage within the healthcare settings and monitors for any diversion and abuse. AcelRx will de-certify healthcare settings that are non-compliant with the REMS program.
Zalviso
Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia, or PCA, system. Zalviso is approved in Europe and is in late-stage development in the United States. The Company had initially submitted to the FDA an NDA seeking approval for Zalviso in September 2013 but received a complete response letter, or CRL, on July 25, 2014. Subsequently, the FDA requested an additional clinical study, IAP312, designed to evaluate the effectiveness of changes made to the functionality and usability of the Zalviso device and to take into account comments from the FDA on the study protocol. In the IAP312 study, for which top-line results were announced in August 2017, Zalviso met safety, satisfaction and device usability expectations. These results will supplement the three Phase 3 trials already completed in the Zalviso NDA resubmission.
Termination of Grünenthal Agreements
On December 16, 2013, AcelRx and Grünenthal entered into a Collaboration and License Agreement, or the License Agreement, which was amended effective July 17, 2015 and September 20, 2016, or the Amended License Agreement, which granted Grünenthal rights to commercialize the Zalviso PCA system, or the Product, in the 28 European Union, or EU, member states, at the time of the agreement, plus Switzerland, Liechtenstein, Iceland, Norway and Australia (collectively, the Zalviso Territory) for human use in pain treatment within, or dispensed by, hospitals, hospices, nursing homes and other medically supervised settings, (collectively, the Field). In September 2015, the EC granted marketing approval for the marketing authorization application, or MAA, previously submitted to the EMA, for Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. On December 16, 2013, AcelRx and Grünenthal, entered into a Manufacture and Supply Agreement, or the MSA, and together with the License Agreement, the Agreements. Under the MSA, the Company exclusively manufactured and supplied the Product to Grünenthal for the Field in the Zalviso Territory. On July 22, 2015, the Company and Grünenthal amended the MSA, or the Amended MSA, effective as of July 17, 2015. The Amended MSA and the Amended License Agreement are referred to as the Grünenthal Agreements.
On May 18, 2020, the Company received a notice from Grünenthal that it had exercised its right to terminate the Grünenthal Agreements, effective November 13, 2020. The terms of the Grünenthal Agreements were extended to May 12, 2021 to enable Grünenthal to sell down its Zalviso inventory, a right it had under the Grünenthal Agreements. The rights to market and sell Zalviso in the Zalviso Territory reverted back to the Company on May 12, 2021.
Principles of Consolidation
The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Refer to Note 7 “Liability Related to Sale of Future Royalties” for additional information.
Reclassifications
Certain prior period amounts in the Condensed Consolidated Financial Statements have been reclassified to conform to the current period's presentation.
Basis of Presentation
The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP, for interim financial information and the rules and regulations of the SEC. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included.
Operating results for the three and six months ended June 30, 2021, are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. The Condensed Consolidated Balance Sheet as of December 31, 2020, was derived from the Company’s audited financial statements as of December 31, 2020, included in the Company’s Annual Report on Form 10-K filed with the SEC. These financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, which includes a broader discussion of the Company’s business and the risks inherent therein.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the Condensed Consolidated Financial Statements and accompanying notes. Management evaluates its estimates on an ongoing basis including critical accounting policies. Estimates are based on historical experience and on various other market-specific and other relevant assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates.
Significant Accounting Policies
The Company’s significant accounting policies are detailed in its Annual Report on Form 10-K for the year ended December 31, 2020. There have been no significant changes to the Company’s significant accounting policies during the three and six months ended June 30, 2021, from those previously disclosed in its 2020 Annual Report on Form 10-K, except to reflect that the Company applies the graded-vesting attribution method to awards with market conditions that include graded-vesting features. Additionally, the Company uses the Monte Carlo Simulation model to evaluate the derived service period and fair value of awards with market conditions, including assumptions of historical volatility and risk-free interest rate commensurate with the vesting term.
Recently Issued Accounting Pronouncements
In June 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2016-13, “Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments,” or ASU 2016-13. ASU 2016-13 replaces the incurred loss impairment model in current GAAP with a model that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to determine credit loss estimates. ASU 2016-13 is effective for the Company beginning January 1, 2023, with early adoption allowed beginning January 1, 2020. In May 2019, the FASB issued ASU 2019-05, “Financial Instruments – Credit Losses,” or ASU 2019-05, to allow entities to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost upon adoption of the new credit losses standard. The new effective dates and transition align with those of ASU 2016-13. Management is currently assessing the date of adoption and the impact ASU 2016-13 and ASU 2019-05 will have on the Company, but it does not anticipate adoption of these new standards to have a material impact on the Company’s financial position, results of operations or cash flows.
In March 2020, the FASB issued ASU 2020-04, “Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting.” The amendments provide optional guidance for a limited time to ease the potential burden in accounting for reference rate reform. The new guidance provides optional expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships and other transactions affected by reference rate reform if certain criteria are met. The amendments apply only to contracts and hedging relationships that reference LIBOR or another reference rate expected to be discontinued due to reference rate reform. These amendments are effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into or evaluated on or before December 31, 2022. The Company is currently evaluating its contracts and the optional expedients provided by the new standard, but it does not anticipate its adoption to have a material impact on the Company’s financial position, results of operations or cash flows.
2. Investments and Fair Value Measurement
Investments
The Company classifies its marketable securities as available-for-sale and records its investments at fair value. Available-for-sale securities are carried at estimated fair value based on quoted market prices or observable market inputs of almost identical assets, with the unrealized holding gains and losses included in accumulated other comprehensive income (loss). Marketable securities which have maturities beyond one year as of the end of the reporting period are classified as non-current.
The table below summarizes the Company’s cash, cash equivalents and short-term investments (in thousands):
| As of June 30, 2021 | ||||||||||||||||
| Amortized Cost | Gross Unrealized | Gross Unrealized | Fair | |||||||||||||
| Cash and cash equivalents: | ||||||||||||||||
| Cash | $ | $ | $ | $ | ||||||||||||
| Money market funds | ||||||||||||||||
| Total cash and cash equivalents | ||||||||||||||||
| Short-term investments: | ||||||||||||||||
| Commercial paper | ||||||||||||||||
| Corporate debt securities | ||||||||||||||||
| Total short-term investments | ||||||||||||||||
| Total cash, cash equivalents and short-term investments | $ | $ | $ | $ | ||||||||||||
| As of December 31, 2020 | ||||||||||||||||
| Amortized Cost | Gross Unrealized | Gross Unrealized | Fair | |||||||||||||
| Cash and cash equivalents: | ||||||||||||||||
| Cash | $ | $ | $ | $ | ||||||||||||
| Money market funds | ||||||||||||||||
| Commercial paper | ||||||||||||||||
| Total cash and cash equivalents | ||||||||||||||||
| Short-term investments: | ||||||||||||||||
| U.S. government agency securities | ||||||||||||||||
| Commercial paper | ||||||||||||||||
| Total short-term investments | ||||||||||||||||
| Total cash, cash equivalents and short-term investments | $ | $ | $ | $ | ||||||||||||
There were
As of June 30, 2021, and December 31, 2020, the contractual maturity of all investments held was less than one year.
Fair Value Measurement
The Company’s financial instruments consist of Level I and II assets and Level III liabilities. Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. For Level II instruments, the Company estimates fair value by utilizing third party pricing services in developing fair value measurements where fair value is based on valuation methodologies such as models using observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. Such Level II instruments typically include U.S. treasury, U.S. government agency securities, corporate debt securities and commercial paper. As of June 30, 2021, and December 31, 2020, the Company held, in addition to Level II assets, a contingent put option liability associated with the Loan Agreement with Oxford. See Note 5 “Long-Term Debt” for further description. The Company’s estimate of fair value of the contingent put option liability was determined using a risk-neutral valuation model, wherein the fair value of the underlying debt facility is estimated both with and without the presence of the default provisions, holding all other assumptions constant. The resulting difference between the two estimated fair values is the estimated fair value of the default provisions, or the contingent put option, which is included under other long-term liabilities on the Condensed Consolidated Balance Sheets. Changes to the estimated fair value of this liability is recorded in interest income and other income (expense), net in the Condensed Consolidated Statements of Comprehensive Loss. The fair value of the underlying debt facility is estimated by calculating the expected cash flows in consideration of an estimated probability of default and expected recovery rate in default and discounting such cash flows back to the reporting date using a risk-free rate.
The following table sets forth the fair value of the Company’s financial assets and liabilities by level within the fair value hierarchy (in thousands):
| As of June 30, 2021 | ||||||||||||||||
| Fair Value | Level I | Level II | Level III | |||||||||||||
| Assets | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Commercial paper | ||||||||||||||||
| Corporate debt securities | ||||||||||||||||
| Total assets measured at fair value | $ | $ | $ | $ | ||||||||||||
| Liabilities | ||||||||||||||||
| Contingent put option liability | $ | $ | $ | $ | ||||||||||||
| Total liabilities measured at fair value | $ | $ | $ | $ | ||||||||||||
| As of December 31, 2020 | ||||||||||||||||
| Fair Value | Level I | Level II | Level III | |||||||||||||
| Assets | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| U.S. government agency securities | ||||||||||||||||
| Commercial paper | ||||||||||||||||
| Total assets measured at fair value | $ | $ | $ | $ | ||||||||||||
| Liabilities | ||||||||||||||||
| Contingent put option liability | $ | $ | $ | $ | ||||||||||||
| Total liabilities measured at fair value | $ | $ | $ | $ | ||||||||||||
The following tables set forth a summary of the changes in the fair value of the Company’s Level III financial liabilities for the three and six months ended June 30, 2021 and 2020 (in thousands):
| Three Months | Six Months | |||||||
| Fair value—beginning of period | $ | $ | ||||||
| Change in fair value of contingent put option associated with the Loan Agreement | ( | ) | ( | ) | ||||
| Fair value—end of period | $ | $ | ||||||
| Three Months | Six Months | |||||||
| Fair value—beginning of period | $ | $ | ||||||
| Change in fair value of contingent put option associated with the Loan Agreement | ( | ) | ||||||
| Fair value—end of period | $ | $ | ||||||
3. Inventories, net
Inventories consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value and consist of the following (in thousands):
| Balance as of | ||||||||
| June 30, 2021 | December 31, 2020 | |||||||
| Raw materials | $ | $ | ||||||
| Work-in-process | ||||||||
| Finished goods | ||||||||
| Total | $ | $ | ||||||
The Company recorded inventory impairment charges of $
4. Revenue from Contracts with Customers
The following table summarizes revenue from contracts with customers for the three and six months ended June 30, 2021 and 2020 into categories that depict how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors (in thousands):
| Three months ended | Six months ended | |||||||
| Product sales: | ||||||||
| DSUVIA | $ | $ | ||||||
| Zalviso | ||||||||
| Total product sales | ||||||||
| Contract and collaboration revenue: | ||||||||
| Non-cash royalty revenue related to Royalty Monetization (Note 7) | ||||||||
| Royalty revenue | ||||||||
| Total revenues from contract and other collaboration | ||||||||
| Total revenue | $ | $ | ||||||
| Three months ended | Six months ended | |||||||
| Product sales: | ||||||||
| DSUVIA | $ | $ | ||||||
| Zalviso | ||||||||
| Total product sales | ||||||||
| Contract and collaboration revenue: | ||||||||
| Non-cash royalty revenue related to Royalty Monetization (Note 7) | ||||||||
| Royalty revenue | ||||||||
| Other revenue | ||||||||
| Total revenues from contract and other collaboration | ||||||||
| Total revenue | $ | $ | ||||||
For additional details on the Company’s accounting policy regarding revenue recognition, refer to Note 1 “Organization and Summary of Significant Accounting Policies - Revenue from Contracts with Customers” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.
Product Sales
The Company’s commercial launch of DSUVIA in the United States occurred in the first quarter of 2019. Zalviso was sold in Europe by the Company’s collaboration partner, Grünenthal, through May 12, 2021.
Contract and Other Collaboration
Contract and other collaboration revenue includes revenue under the Grünenthal Agreements related to research and development services, non-cash royalty revenue related to the Royalty Monetization and royalty revenue for sales of Zalviso in Europe.
Contract Liability
The following table presents changes in the Company’s contract liability for the six months ended June 30, 2021 (in thousands):
| Balance at Beginning of the Period | Additions | Deductions | Balance at the end of the Period | |||||||||||||
| Contract liability: | ||||||||||||||||
| Deferred revenue – Grünenthal Agreements | $ | $ | $ | ( | ) | $ | ||||||||||
| Deferred revenue | $ | $ | $ | ( | ) | $ | ||||||||||
For the three and six months ended June 30, 2021 and 2020, the Company recognized the following revenue from performance obligations satisfied or eliminated under the Grünenthal Agreements (in thousands):
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Amounts included in contract liabilities at the beginning of the period: | ||||||||||||||||
| Performance obligations satisfied | $ | $ | $ | $ | ||||||||||||
| Performance obligations eliminated upon termination | ||||||||||||||||
| New activities in the period from performance obligations satisfied: | ||||||||||||||||
| Performance obligations satisfied | ||||||||||||||||
| Total revenue from performance obligations satisfied or eliminated | $ | $ | $ | $ | ||||||||||||
5. Long-Term Debt
Loan Agreement with Oxford
On May 30, 2019, the Company entered into the Loan Agreement with Oxford Finance LLC, or Oxford, as the Lender. Under the Loan Agreement, the Lender made a term loan to the Company in an aggregate principal amount of $
In connection with the Loan Agreement, on May 30, 2019, the Company issued warrants to the Lender and its affiliates, or the Warrants, which are exercisable for an aggregate of
As of June 30, 2021, the accrued balance due under the Loan Agreement with Oxford was $
Non-Interest Bearing Payments for the Construction of Leasehold Improvements
In August 2019, the Company entered into a Site Readiness Agreement, or SRA, with Catalent Pharma Solutions, LLC, or Catalent, in contemplation of entering into a commercial supply agreement for its product DSUVIA at a future date. Under the SRA, the Company is building out a suite within Catalent’s production facility in Kansas City. If additional equipment and facility modifications are required to meet the Company’s product needs, the Company may be required to contribute to the cost of such additional equipment and facility modifications. The Company has determined that it is the owner of the leasehold improvements related to the build-out which will be paid for in four installments of $
6. Leases
Office Leases
The Company leased office and laboratory space for its corporate headquarters, located at 301 – 351 Galveston Drive, Redwood City, California, and had entered into an agreement to sublease approximately
On March 26, 2021, the Company entered into a Lease Termination Agreement with its landlord and a Sublease Termination Agreement with its sublessee, to terminate the lease and sublease agreements at its corporate headquarters. The termination of both the lease and sublease was effective on April 30, 2021. As of the date of the Lease Termination Agreement, the Company remeasured its lease liability and recorded a gain of $
On March 26, 2021, the Company entered into a Sublease Agreement to sublet space for its corporate headquarters, located at 25821 Industrial Boulevard, Hayward, California. The Sublease Agreement commencement date is April 1, 2021. The Sublease Agreement is for a period of years and three months with monthly rental payments of $
Contract Manufacturing Leases
On April 21, 2021, the Company entered into a Commercial Supply Agreement, or the CSA, with Catalent Pharma Solutions, LLC, or Catalent, effective March 31, 2021, under which Catalent will provide certain services to the Company in connection with the processing and packaging of a packaged single dose applicator containing the sublingual tablet 30 mcg sufentanil dosage form contained in the pharmaceutical product, DSUVIA (sufentanil), intended for commercialization.
The term of the CSA is for a period of years from the first date upon which the FDA approves Catalent as a manufacturer of DSUVIA in the United States, or the Commencement Date. The term shall automatically be extended for successive -year periods, unless and until one party gives the other party at least 24 months’ prior written notice of its desire to terminate as of the end of the then-current term.
The Company will pay Catalent an annual fee of $
The Company has determined that the fixed fees in the CSA are in-substance lease payments. The Company concluded that this agreement contains an embedded lease as the clean rooms have been built specifically for production of the Company’s product and their use is effectively controlled by the Company as it has sole use over the space during the term of the agreement. The Company accounts for the agreement as an operating lease and has evaluated the non-cancelable lease term to be through the binding commitment date of May 15, 2027.
In addition, the Company has entered into an agreement for commercial supply manufacturing services related to the Company’s Zalviso drug product with a contract manufacturing organization, which it accounts for as an operating lease.
The components of lease expense are presented in the following table (in thousands):
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating lease costs | $ | $ | $ | $ | ||||||||||||
| Gain on derecognition of operating lease | ( | ) | ||||||||||||||
| Sublease income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Loss on termination of sublease | ||||||||||||||||
| Net lease costs | $ | $ | $ | $ | ||||||||||||
The weighted average remaining lease term and discount rate related to the operating leases are presented in the following table:
| June 30, 2021 | ||||
| Weighted-average remaining term – operating lease (in years) | ||||
| Weighted-average discount rate – operating lease | % | |||
Future minimum lease payments as of June 30, 2021 are presented in the following table (in thousands):
| Year: | ||||
| 2021 (remaining nine months) | $ | |||
| 2022 | ||||
| 2023 | ||||
| 2024 | ||||
| 2025 | ||||
| Thereafter | ||||
| Total future minimum lease payments | ||||
| Less imputed interest | ( | ) | ||
| Total | $ |
Reported as:
| Operating lease liabilities | $ | |||
| Operating lease liabilities, current portion | ( | ) | ||
| Operating lease liabilities, net of current portion | $ |
7. Liability Related to Sale of Future Royalties
In September 2015, the Company entered into the Royalty Monetization with PDL for which it received gross proceeds of $
The Company periodically assesses the expected royalty and milestone payments using a combination of historical results, internal projections and forecasts from external sources. To the extent such payments are greater or less than the Company’s initial estimates or the timing of such payments is materially different than its original estimates, the Company will prospectively adjust the amortization of the liability and the effective interest rate. During the three months ended June 30, 2020, Grünenthal notified the Company that it was terminating the Amended License Agreement, effective November 13, 2020. The terms of the Grünenthal Agreements were extended to May 12, 2021 to enable Grünenthal to sell down its Zalviso inventory. The rights to market and sell Zalviso in the Zalviso Territory reverted back to the Company on May 12, 2021. There is a continuing obligation on the Company’s part, through the term of the Royalty Monetization with SWK (assignee of PDL), to use commercially reasonable efforts to negotiate a replacement license agreement, or New Arrangement. If the Company is unable to find a New Arrangement, a contingent gain of up to approximately $
The effective interest rate over the life of the liability will be
The following table shows the activity within the liability account for the six months ended and the period from inception to June 30, 2021 (in thousands):
| Six months ended | Period from | |||||||
| Liability related to sale of future royalties — beginning balance | $ | $ | ||||||
| Proceeds from sale of future royalties | ||||||||
| Non-cash royalty revenue | ( | ) | ( | ) | ||||
| Non-cash interest (income) expense recognized | ( | ) | ||||||
| Liability related to sale of future royalties as of June 30, 2021 | ||||||||
| Less: current portion | ||||||||
| Liability related to sale of future royalties — net of current portion | $ | $ | ||||||
As royalties are remitted to SWK from ARPI LLC, as described in Note 1 “Organization and Summary of Significant Accounting Policies - Non-Cash Interest Income (Expense) on Liability Related to Sale of Future Royalties” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, the balance of the liability will be effectively repaid over the life of the agreement. The Company will record non-cash royalty revenues and non-cash interest expense within its Condensed Consolidated Statements of Comprehensive Loss over the term of the Royalty Monetization.
8. Legal Proceedings
On June 8, 2021, a securities class action complaint was filed in the U.S. District Court for the Northern District of California against the Company and
On July 6, 2021, a purported shareholder derivative complaint was filed in the U.S. District Court for the Northern District of California. The complaint names as defendants
The Company believes that these lawsuits are without merit, and intends to vigorously defend against them. Given the uncertainty of litigation, the preliminary stage of the cases, and the legal standards that must be met for, among other things, class certification and success on the merits, the Company cannot estimate the reasonably possible loss or range of loss that may result from these actions.
9. Stockholders’ Equity
Common Stock
Underwritten Public Offering
On January 22, 2021, the Company completed an underwritten public offering in which the Company issued and sold
ATM Agreement
The Company has entered into a Controlled Equity OfferingSM Sales Agreement, or the ATM Agreement, with Cantor Fitzgerald & Co., or Cantor, as agent, pursuant to which the Company may offer and sell, from time to time through Cantor, shares of the Company’s common stock having an aggregate offering price of up to $
During the three and six months ended June 30, 2021, the Company issued and sold approximately
Amended Stock Plan
Amended 2020 Plan
On June 17, 2021, at the 2021 Annual Meeting of Stockholders of the Company, upon the recommendation of the Company’s Board of Directors, the Company’s stockholders approved an amendment to the Company’s 2020 Equity Incentive Plan, or 2020 Plan, or as amended, the Amended 2020 Plan, to increase the number of authorized shares reserved for issuance thereunder by
10. Stock-Based Compensation
The Company recorded total stock-based compensation expense for stock options, stock awards and awards made under the Amended 2011 ESPP as follows (in thousands):
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Cost of goods sold | $ | $ | $ | $ | ||||||||||||
| Research and development | ||||||||||||||||
| Selling, general and administrative | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
As of June 30, 2021, there were, in the aggregate,
11. Net Loss per Share of Common Stock
The Company’s basic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share of common stock is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, options to purchase common stock, RSUs, and warrants to purchase common stock were considered to be common stock equivalents. In periods with a reported net loss, common stock equivalents are excluded from the calculation of diluted net loss per share of common stock as their effect is antidilutive.
The following outstanding shares of common stock equivalents were excluded from the computation of diluted net loss per share of common stock for the periods presented because including them would have been antidilutive:
| June 30, | ||||||||
| 2021 | 2020 | |||||||
| ESPP, RSUs and stock options to purchase common stock | ||||||||
| Common stock warrants | ||||||||
12. Subsequent Events
Out-License Agreement (DZUVEO)
On July 14, 2021, the Company entered into a License and Commercialization Agreement, or the DZUVEO Agreement, with Aguettant, pursuant to which Aguettant obtained the exclusive right to develop and commercialize DZUVEO in the European Union, Norway, Iceland, Liechtenstein, Andorra, Vatican City, Monaco, Switzerland and the United Kingdom, or the DZUVEO Territory, for the management of acute moderate to severe pain in adults in medically monitored settings. The Company will supply Aguettant with primary packaged product and Aguettant will then complete secondary packaging of the finished product.
The DZUVEO Agreement has an initial term of ten (
The Company is entitled to receive up to € million in a combination of up-front and sales-based milestone payments. Aguettant will purchase product from the Company at an agreed price, or the DZUVEO Purchase Price, subject to adjustment. Aguettant will also make revenue share payments that, combined with the DZUVEO Purchase Price, range from
Beginning in the third marketing year, the parties will establish binding annual minimums for purchase orders to be submitted by Aguettant. Aguettant has the right to grant sublicenses to its affiliates or, with the prior approval of the Company, third parties, subject to certain limitations.
The DZUVEO Agreement also provides Aguettant with a right of first negotiation for eighteen (18) months before the Company can enter into a collaboration regarding Zalviso in Europe.
In-License Agreement
On July 14, 2021, the Company entered into a License and Commercialization Agreement, or the PFS Agreement, with Aguettant pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe containing 10 ml of a solution of 3 mg/ml ephedrine hydrochloride for injection, and (ii) a phenylephrine prefilled syringe containing 10 ml of a solution of 50 mcg/ml phenylephrine hydrochloride for injection. Aguettant will supply the Company with the products for use in commercialization, if they are approved in the U.S.
The PFS Agreement has an initial term of ten (
Aguettant is entitled to receive up to $
The Company and Aguettant will agree on minimum sales obligations twelve (
The Company has the right to grant sublicenses to its affiliates or, with the prior approval of Aguettant, third parties, subject to certain limitations.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with the unaudited financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q, or Form 10-Q, and with the audited Consolidated Financial Statements and related notes thereto included as part of our Annual Report on Form 10-K for the year ended December 31, 2020, or Annual Report.
About AcelRx Pharmaceuticals, Inc.
We are a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.
Our Portfolio
The following table summarizes our portfolio of products and product candidates.
| Product/Product Candidate |
Description |
Target Use |
Status |
|||
| DSUVIA® |
Sufentanil sublingual tablet, 30 mcg |
Moderate-to-severe acute pain in a medically supervised setting, administered by a healthcare professional |
Received U.S. Food and Drug Administration, or FDA, approval in November 2018; commercial launch began first quarter of 2019. |
|||
| DZUVEO® |
Sufentanil sublingual tablet, 30 mcg |
Moderate-to-severe acute pain in a medically monitored setting, administered by a healthcare professional |
Granted European Commission, or EC, marketing approval in June 2018. Sunset date extended to December 31, 2022 by EC. To be commercialized in Europe by Laboratoire Aguettant. |
|||
| Zalviso® |
Sufentanil sublingual tablet system, 15 mcg |
Moderate-to-severe acute pain in the hospital setting, administered by the patient as needed |
In the U.S., positive results from Phase 3 trial, IAP312, announced in August 2017. Currently evaluating the timing of the resubmission of the New Drug Application, or NDA, which is in part dependent on the finalization of the FDA’s new opioid approval guidelines and process. Approved in the European Union, where it was marketed commercially by Grünenthal through May 12, 2021. We intend to find a replacement license agreement for Zalviso in Europe. |
|||
| Ephedrine |
Ephedrine pre-filled syringe, containing 10 ml of a solution of 3 mg/ml ephedrine hydrochloride for injection |
Clinically important hypotension occurring in the setting of anesthesia |
Product candidate licensed from Laboratoire Aguettant, or Aguettant, pending submission for approval to FDA under New Drug Application, or NDA. Approved in the European Union, marketed by Aguettant. |
|||
| Phenylephrine |
Phenylephrine prefilled syringe containing 10 ml of a solution of 50 mcg/ml phenylephrine hydrochloride for injection |
Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. |
Product candidate licensed from Aguettant, pending submission for approval to FDA under New Drug Application, or NDA. Approved in the European Union, marketed by Aguettant. |
|||
| ARX-02 |
Higher Strength Sufentanil Sublingual Tablet |
Cancer breakthrough pain in opioid-tolerant patients |
Phase 2 clinical trial and End of Phase 2 meeting completed. Investigational New Drug, or IND, application was inactivated. Future development contingent upon identification of corporate partnership resources. |
|||
| ARX-03 |
Combination Sufentanil/Triazolam Sublingual Tablet |
Mild sedation and pain relief during painful procedures in a physician’s office |
Phase 2 clinical trial and End of Phase 2 meeting completed. IND application was inactivated. Future development contingent upon identification of corporate partnership resources. |
Out-License Agreement (DZUVEO)
On July 14, 2021, we entered into a License and Commercialization Agreement, or the DZUVEO Agreement, with Aguettant pursuant to which Aguettant obtained the exclusive right to develop and commercialize DZUVEO in the European Union, Norway, Iceland, Liechtenstein, Andorra, Vatican City, Monaco, Switzerland and the United Kingdom, or the DZUVEO Territory, for the management of acute moderate to severe pain in adults in medically monitored settings. We will supply Aguettant with primary packaged product and Aguettant will then complete secondary packaging of the finished product. We are entitled to receive up to €47.0 million in a combination of up-front and sales-based milestone payments. Refer to Note 12 “Subsequent Events” in the accompanying notes to the Condensed Consolidated Financial Statements for additional information.
In-License Agreement
On July 14, 2021, we entered into a License and Commercialization Agreement, or the PFS Agreement, with Aguettant pursuant to which we obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe containing 10 ml of a solution of 3 mg/ml ephedrine hydrochloride for injection, and (ii) a phenylephrine prefilled syringe containing 10 ml of a solution of 50 mcg/ml phenylephrine hydrochloride for injection. Aguettant will supply the Company with the products for use in commercialization, if they are approved in the U.S. Aguettant is entitled to receive up to $24 million in sales-based milestone payments. Refer to Note 12 “Subsequent Events” in the accompanying notes to the Condensed Consolidated Financial Statements for additional information.
General Trends and Outlook
COVID-19-related
Government-mandated orders and related safety policies on account of the COVID-19 pandemic continue to prevent us from operating our business in the normal course. Beginning in early 2020, state and local officials issued orders in response to the pandemic which included, among other things, requirements for residents to shelter in place and for non-essential businesses to cease activities at facilities within certain cities, counties, and states. State and local officials have taken different approaches to these orders, and some have not issued any such orders. Once issued, the orders have been relaxed and then tightened, depending on the rate of COVID-19 cases. As a result of these orders, we implemented a work from home policy for our California-based employees and we continue to adhere to the various and diverse orders issued by government officials in the jurisdictions in which we operate. In addition, some hospitals, ambulatory surgery centers and other healthcare facilities have barred visitors that are not caregivers or mission-critical and otherwise restricted access to such facilities. As a result, the educational and promotional efforts of our commercial and medical affairs personnel have been substantially reduced, and in some cases, stopped. Cancellation or delays of formulary committee meetings and delays of elective surgeries have also affected the pace of formulary approvals and, consequently, the rate of adoption and use of DSUVIA. We expect our near-term sales volumes to continue to be adversely impacted as long as access to healthcare facilities by our commercial and medical affairs personnel continues to be limited, especially in light of the rise in COVID-19 cases associated with the Delta variant. We will continue to evaluate the impact on our revenues and related metrics and operating expenses during this period and assess the need to adjust our expenses and expectations.
As a result of international travel restrictions, the timing for testing and acceptance of our DSUVIA fully automated packaging line, and subsequent FDA approval, has been delayed. Based on our best estimate, now that the line has been installed, we expect FDA approval in 2022.
We will continue to engage with various elements of our supply chain and distribution channel, including our customers, contract manufacturers, and logistics and transportation providers, to meet demand for products and to remain informed of any challenges within our supply chain. We continue to monitor demand and intend to adapt our plans as needed to continue to drive our business and meet our obligations during the evolving COVID-19 pandemic. However, if the COVID-19 pandemic continues and persists for an extended period of time, we may face disruptions to our supply chain and operations, and associated delays in the manufacturing and supply of our products. Such supply disruptions may adversely impact our ability to generate sales of and revenues from our products and our business, financial condition, results of operations and growth prospects could be adversely affected.
As the global pandemic of COVID-19 continues to rapidly evolve, it could result in a significant long-term disruption of global financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity. The extent to which the COVID-19 pandemic impacts our business, our ability to generate sales of and revenues from our approved products, and our future clinical development and regulatory efforts will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions, quarantines and social distancing requirements in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the virus.
Financial Overview
We have incurred net losses and generated negative cash flows from operations since inception and expect to incur losses in the future as we continue commercialization activities to support the U.S. launch of DSUVIA, support European sales of DZUVEO by Aguettant, and of Zalviso by any replacement partner, and fund any future research and development activities needed to support the FDA regulatory review of our product candidates. 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.
We will incur capital expenditures related to our fully automated packaging line for DSUVIA, which has now been installed, and for which we expect FDA approval in 2022. We anticipate that the fully automated line for DSUVIA will contribute to a significant decrease in costs of goods sold in 2022 and beyond.
Our net loss for the three and six months ended June 30, 2021 was $9.9 million and $18.8 million, respectively, compared to net losses of $6.6 million and $22.5 million for the three and six months ended June 30, 2020, respectively. As of June 30, 2021, we had an accumulated deficit of $457.3 million. As of June 30, 2021, we had cash, cash equivalents and short-term investments totaling $55.3 million compared to $42.9 million as of December 31, 2020.
Critical Accounting Estimates
The accompanying discussion and analysis of our financial condition and results of operations are based upon our unaudited Condensed Consolidated Financial Statements and the related disclosures, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts in our financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. To the extent that there are material differences between these estimates and actual results, our future financial statement presentation, financial condition, results of operations and cash flows will be affected. Our critical accounting policies and estimates are detailed in our Annual Report.
There have been no significant changes to our critical accounting policies or significant judgements and estimates for the three and six months ended June 30, 2021, from those previously disclosed in our Annual Report, except to reflect that we apply the graded-vesting attribution method to awards with market conditions that include graded-vesting features. Additionally, we use the Monte Carlo Simulation model to evaluate the derived service period and fair value of awards with market conditions, including assumptions of historical volatility and risk-free interest rate commensurate with the vesting term.
Results of Operations
Our results of operations have fluctuated from period to period and may continue to fluctuate in the future, based upon the progress of our commercial launch of DSUVIA, our research and development efforts, variations in the level of expenditures related to commercial launch, development efforts and debt service obligations during any given period, and the uncertainty as to the extent and magnitude of the impact from the COVID-19 pandemic. Results of operations for any period may be unrelated to results of operations for any other period. In addition, historical results should not be viewed as indicative of future operating results. In particular, to the extent our commercial and medical affairs personnel continue to be subject to varying levels of restriction on accessing hospitals and ambulatory surgical centers due to COVID-19, and to the extent government authorities and certain healthcare providers are continuing to limit elective surgeries, we expect our sales volume to be adversely affected.
Three and Six Months Ended June 30, 2021 and 2020
Revenue
Product Sales Revenue
Product sales revenue consists of sales of DSUVIA in the U.S. and Zalviso in Europe.
Product sales revenue by product for the three and six months ended June 30, 2021 and 2020, was as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||||||||
| 2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
|||||||||||||||||||||||||
| (In thousands, except percentages) |
||||||||||||||||||||||||||||||||
| DSUVIA |
$ | 392 | $ | 2 | $ | 390 | 19,500 | % | $ | 573 | $ | 157 | $ | 416 | 265 | % | ||||||||||||||||
| Zalviso |
— | 301 | (301 | ) | (100 | )% | 270 | 420 | (150 | ) | (36 | )% | ||||||||||||||||||||
| Total product sales revenue |
$ | 392 | $ | 303 | $ | 89 | 29 | % | $ | 843 | $ | 577 | $ | 266 | 46 | % | ||||||||||||||||
The increase in product sales revenue for the three and six months ended June 30, 2021, as compared to the three and six months ended June 30, 2020, was primarily the result of increased sales of DSUVIA. Zalviso was sold by Grünenthal GmbH, or Grünenthal, under the Collaboration and License Agreement and the Manufacture and Supply Agreement, or the Grünenthal Agreements in the European Union through May 12, 2021.
Contract and Other Collaboration Revenue
Contract and other collaboration revenue included revenue under the Grünenthal Agreements related to research and development services, non-cash royalty revenue related to the sale of the majority of our royalty rights and certain commercial sales milestones under the Grünenthal Agreements to SWK Funding, LLC, or SWK, (assignee of PDL BioPharma, Inc., or PDL), in a transaction referred to as the Royalty Monetization, and royalty revenue for sales of Zalviso in Europe.
Contract and other collaboration revenue for the three and six months ended June 30, 2021 and 2020, was as follows (in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||||||||
| 2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
|||||||||||||||||||||||||
| (In thousands, except percentages) |
||||||||||||||||||||||||||||||||
| Non-cash royalty revenue related to Royalty Monetization (See Note 7) |
$ | 38 | $ | 37 | $ | 1 | 3 | % | $ | 83 | $ | 121 | $ | (38 | ) | (31 | )% | |||||||||||||||
| Royalty revenue |
13 | 12 | 1 | 8 | % | 28 | 40 | (12 | ) | (30 | )% | |||||||||||||||||||||
| Other revenue |
— | 2,572 | (2,572 | ) | (100 | )% | — | 2,572 | (2,572 | ) | (100 | )% | ||||||||||||||||||||
| Total contract and other collaboration revenue |
$ | 51 | $ | 2,621 | $ | (2,570 | ) | (98 | )% | $ | 111 | $ | 2,733 | $ | (2,622 | ) | (96 | )% | ||||||||||||||
We estimate and recognize royalty revenue and non-cash royalty revenue on a quarterly basis. Adjustments to estimated revenue are recognized in the subsequent quarter based on actual revenue earned per the royalty reports received from Grünenthal. As mentioned above, Grünenthal has terminated the Grünenthal Agreements, accordingly the rights to market and sell Zalviso in Europe reverted back to us on May 12, 2021. In May 2020, upon notification of early termination by Grünenthal, we recognized approximately $2.6 million of deferred revenue for the discount on Zalviso manufacturing services which were no longer a performance obligation.
Cost of Goods Sold
We commenced commercial sales of DSUVIA in the first quarter of 2019.
Total cost of goods sold for the three and six months ended June 30, 2021 and 2020, was as follows (in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||||||||
| 2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
|||||||||||||||||||||||||
| (In thousands, except percentages) |
||||||||||||||||||||||||||||||||
| Direct costs |
$ | 124 | $ | 379 | $ | (255 | ) | (67 | )% | $ | 435 | $ | 625 | $ | (190 | ) | (30 | )% | ||||||||||||||
| Indirect costs |
916 | 991 | (75 | ) | (8 | )% | 1,645 | 2,256 | (611 | ) | (27 | )% | ||||||||||||||||||||
| Total costs of goods sold |
$ | 1,040 | $ | 1,370 | $ | (330 | ) | (24 | )% | $ | 2,080 | $ | 2,881 | $ | (801 | ) | (28 | )% | ||||||||||||||
Direct costs from contract manufacturers for DSUVIA and Zalviso totaled $0.1 million and $0.4 million, respectively, in the three and six months ended June 30, 2021, and included inventory impairment charges of $0 and $0.1 million, respectively, primarily related to Zalviso component parts inventory. Direct costs from contract manufacturers for DSUVIA and Zalviso in the three and six months ended June 30, 2020 totaled $0.4 million and $0.6 million, respectively, and included inventory impairment charges of $0.3 million, and $0.4 million, respectively. In the six months ended June 30, 2020, $0.3 million of these charges related to the termination of the Grünenthal Agreements, while $0.1 million related to DSUVIA inventory that may expire before being sold. Direct cost of goods sold for DSUVIA and Zalviso includes the inventory costs of the active pharmaceutical ingredient, or API, third-party contract manufacturing costs, estimated warranty costs, packaging and distribution costs, shipping, handling and storage costs.
The indirect costs to manufacture DSUVIA and Zalviso totaled $0.9 million and $1.6 million in the three and six months ended June 30, 2021, respectively, while the indirect costs to manufacture DSUVIA and Zalviso totaled $1.0 million and $2.3 million in the three and six months ended June 30, 2020, respectively. Indirect costs include internal personnel and related costs for purchasing, supply chain, quality assurance, depreciation and related expenses.
Research and Development Expenses
The majority of our operating expenses to date have been for research and development activities related to Zalviso and DSUVIA. Research and development expenses included the following:
| • |
expenses incurred under agreements with contract research organizations and clinical trial sites; |
| • |
employee-related expenses, which include salaries, benefits and stock-based compensation; |
| • |
payments to third party pharmaceutical and engineering development contractors; |
| • |
payments to third party manufacturers; |
| • |
depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, and equipment and laboratory and other supply costs; and |
| • |
costs for equipment and laboratory and other supplies. |
We expect to incur future research and development expenditures to support the FDA regulatory review of our product candidates. The timing of the resubmission of the Zalviso NDA is in part dependent on the finalization of the FDA’s new opioid approval guidelines and process.
We track external development expenses on a program-by-program basis. Our development resources are shared among all our programs. Compensation and benefits, facilities, depreciation, stock-based compensation, and development support services are not allocated specifically to projects and are considered research and development overhead.
Below is a summary of our research and development expenses for the three and six months ended June 30, 2021 and 2020 (in thousands, except percentages):
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||||||||
| Drug Indication/Description |
2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
||||||||||||||||||||||||
| (In thousands, except percentages) |
||||||||||||||||||||||||||||||||
| DSUVIA |
$ | 182 | $ | 187 | $ | (5 | ) | (3 | )% | $ | 344 | $ | 479 | $ | (135 | ) | (28 | )% | ||||||||||||||
| Zalviso |
6 | 3 | 3 | 100 | % | 12 | 32 | (20 | ) | (63 | )% | |||||||||||||||||||||
| Overhead |
536 | 623 | (87 | ) | (14 | )% | 1,337 | 1,714 | (377 | ) | (22 | )% | ||||||||||||||||||||
| Total research and development expenses |
$ | 724 | $ | 813 | $ | (89 | ) | (11 | )% | $ | 1,693 | $ | 2,225 | $ | (532 | ) | (24 | )% | ||||||||||||||
Research and development expenses for the three and six months ended June 30, 2021 decreased as compared to the three and six months ended June 30, 2020, primarily due to decreases in personnel-related overhead expenses and DSUVIA-related spending.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consisted primarily of salaries, benefits and stock-based compensation for personnel engaged in commercialization, administration, finance and business development activities. Other significant expenses included allocated facility costs and professional fees for general legal, audit and consulting services.
Total selling, general and administrative expenses for the three and six months ended June 30, 2021 and 2020, were as follows (in thousands, except percentages):
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||||||||
| 2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
|||||||||||||||||||||||||
| (In thousands, except percentages) |
||||||||||||||||||||||||||||||||
| Selling, general and administrative expenses |
$ | 8,694 | $ | 7,575 | $ | 1,119 | 15 | % | $ | 16,338 | $ | 20,886 | $ | (4,548 | ) | (22 | )% | |||||||||||||||
Selling, general and administrative expenses increased by $1.1 million and decreased by $4.5 million during the three and six months ended June 30, 2021, as compared to the three and six months ended June 30, 2020, respectively. The increase for the three months ended June 30, 2021, as compared to the three months ended June 30, 2020 is primarily due to a $0.5 million increase in business development expenses and a $0.5 million increase in facilities-related expenses primarily due to the loss on lease termination of our Redwood City lease. The decrease for the six months ended June 30, 2021, as compared to the six months ended June 30, 2020, is primarily due to net decreases in selling, general and administrative expenses including a $2.0 million reduction in personnel-related costs, a decrease in business development expenses of $1.3 million (primarily due to the termination fee of approximately $1.8 million received in June 2020 from Tetraphase Pharmaceuticals, Inc. related to the termination of our merger agreement), a $0.8 million reduction in DSUVIA commercialization-related expenses, such as travel, and net decreases in other selling, general and administrative expenses of $0.4 million.
In March 2020, we eliminated 30 positions, mainly within the commercial organization. For additional information regarding the Restructuring Costs see Note 1 “Organization and Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.
Other Income (Expense)
Total other income (expense) for the three and six months ended June 30, 2021 and 2020, was as follows (in thousands, except percentages):
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||||||||
| 2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
2021 |
2020 |
$ Change 2021 vs. 2020 |
% Change 2021 vs. 2020 |
|||||||||||||||||||||||||
| (In thousands, except percentages) |
||||||||||||||||||||||||||||||||
| Interest expense |
$ | (614 | ) | $ | (872 | ) | $ | 258 | (30 | )% | $ | (1,286 | ) | $ | (1,727 | ) | $ | 441 | (26 | )% | ||||||||||||
| Interest income and other income (expense), net |
(16 | ) | 270 | (286 | ) | (106 | )% | 60 | 205 | (145 | ) | (71 | )% | |||||||||||||||||||
| Non-cash interest income (expense) on liability related to sale of future royalties |
799 | 834 | (35 | ) | (4 | )% | 1,581 | 1,677 | (96 | ) | (6 | )% | ||||||||||||||||||||
| Total other income (expense) |
$ | 169 | $ | 232 | $ | (63 | ) | (27 | )% | $ | 355 | $ | 155 | $ | 200 | 129 | % | |||||||||||||||
Interest expense consisted primarily of interest accrued or paid on our debt obligation agreements and amortization of debt discounts. Interest expense decreased for the three and six months ended June 30, 2021, as compared to the three and six months ended June 30, 2020, primarily as a result of a lower outstanding loan balance. As of June 30, 2021, the accrued balance due under the Loan Agreement with Oxford was $17.2 million. Refer to Note 5 “Long-Term Debt” in the accompanying notes to the Condensed Consolidated Financial Statements for additional information.
Interest income and other income (expense), net, for the three and six months ended June 30, 2021 and 2020, primarily consisted of interest earned on our investments and the change in the fair value of our contingent put option. Interest income decreased in the three and six months ended June 30, 2021 as compared to the three and six months ended June 30, 2020, primarily due to lower yields on our investments.
The non-cash interest income on the liability related to the sale of future royalties is attributable to the Royalty Monetization that we completed in September 2015. As described in Note 7 “Liability Related to Sale of Future Royalties”, the Royalty Monetization has been recorded as debt under the applicable accounting guidance. We periodically assess the expected royalty and milestone payments using a combination of historical results, internal projections and forecasts from external sources. To the extent such payments are greater or less than our initial estimates or the timing of such payments is materially different than our original estimates, we will prospectively adjust the amortization of the liability and the interest rate.
The effective interest income rate for each of the three and six months ended June 30, 2021 and 2020, was approximately 3.6%. We anticipate that we will record approximately $3 million in non-cash interest income related to the Royalty Monetization for the year ending December 31, 2021.
Liquidity and Capital Resources
Liquidity
We have incurred losses and generated negative cash flows from operations since inception. We expect to continue to incur significant losses in 2021 and may incur significant losses and negative cash flows from operations in the future. We have funded our operations primarily through issuance of equity securities, borrowings, payments from Grünenthal, the monetization of certain future royalties and commercial sales milestones from the European sales of Zalviso by Grünenthal, funding of approximately $22.6 million from the DoD, and more recently with revenues from sales of DSUVIA since the commercial launch in the first quarter of 2019.
As of June 30, 2021, we had cash, cash equivalents and investments totaling $55.3 million compared to $42.9 million as of December 31, 2020. The increase was primarily due to net proceeds received from the issuance of common stock in connection with equity offerings in the first quarter of 2021, partially offset by cash required to fund our continuing operations, including debt service, as we continued our commercialization activities for DSUVIA, including installation of our fully automated packaging line for DSUVIA, and business development activities. We anticipate that our existing capital resources will permit us to meet our capital and operational requirements for at least the next twelve months; however, our expectations may change depending on a number of factors including the extent and magnitude of the impact from the COVID-19 pandemic, in particular the negative impact on sales volumes as our sales force is limited in its access to potential customers, our expenditures related to the United States commercial launch of DSUVIA and the timing of business development activities. Our existing capital resources will not be sufficient to fund our operations until such time as we may be able to generate sufficient revenues to sustain our operations.
On January 22, 2021, we completed an underwritten public offering in which we issued and sold 14,500,000 shares of our common stock to the underwriter at a price of $1.7625 per share. On January 27, 2021, the underwriters exercised their option in full and purchased an additional 2,175,000 shares at a price of $1.7625 per share. The total net proceeds from this offering of an aggregate 16,675,000 shares were approximately $28.9 million.
We entered into a Controlled Equity OfferingSM Sales Agreement, or the ATM Agreement, with Cantor Fitzgerald & Co., or Cantor, as agent, pursuant to which we may offer and sell, from time to time through Cantor, shares of our common stock. As of June 30, 2021, we had issued and sold an aggregate of approximately 14.2 million shares of common stock pursuant to the ATM Agreement, for which we had received net proceeds of approximately $42.6 million, after deducting commissions, fees and expenses of approximately $1.2 million. As of June 30, 2021, we have the ability to sell approximately $36.1 million of our common stock under the ATM Agreement.
On May 30, 2019, we entered into the Loan Agreement with Oxford. Under the Loan Agreement, we borrowed an aggregate principal amount of $25.0 million under a term loan. After deducting all loan initiation costs and outstanding interest on the prior loan agreement with Hercules, we received $15.9 million in net proceeds. As of June 30, 2021, the accrued balance under the Loan Agreement was $17.2 million. For more information, see Note 5 “Long-Term Debt” in the accompanying notes to the Condensed Consolidated Financial Statements.
Our cash and investment balances are held in a variety of interest-bearing instruments, including obligations of commercial paper, corporate debt securities, U.S. government sponsored enterprise debt securities and money market funds. Cash in excess of immediate requirements is invested with a view toward capital preservation and liquidity. We do not expect COVID-19 to have a material impact on our high quality, short-dated investments.
Cash Flows
The following is a summary of our cash flows for the periods indicated and has been derived from our Condensed Consolidated Financial Statements which are included elsewhere in this Form 10-Q (in thousands):
| Six Months Ended June 30, |
||||||||
| 2021 |
2020 |
|||||||
| Net cash used in operating activities |
$ | (18,055 | ) | $ | (24,054 | ) | ||
| Net cash (used in) provided by investing activities |
(15,032 | ) | 29,578 | |||||
| Net cash provided by financing activities |
32,140 | 1,581 | ||||||
Cash Flows from Operating Activities
The primary use of cash for our operating activities during these periods was to fund commercial activities for our approved product, DSUVIA. Our cash used in operating activities also reflected changes in our working capital, net of adjustments for non-cash charges, such as depreciation and amortization of our fixed assets, stock-based compensation, non-cash interest income (expense) related to the sale of future royalties and interest expense related to our debt financings.
Cash used in operating activities of $18.1 million during the six months ended June 30, 2021, reflected a net loss of $18.8 million, partially offset by aggregate non-cash charges of $2.0 million and included an approximate $1.3 million net change in our operating assets and liabilities. Non-cash charges included $2.3 million for stock-based compensation expense, $1.6 million in non-cash interest income on the liability related to the Royalty Monetization, and $1.0 million in depreciation and amortization expense. The net change in our operating assets and liabilities included a $1.0 million decrease in accrued liabilities.
Cash used in operating activities of $24.1 million during the six months ended June 30, 2020, reflected a net loss of $22.5 million, partially offset by aggregate non-cash charges of $2.3 million and included an approximate $3.8 million net change in our operating assets and liabilities. Non-cash charges included $2.2 million for stock-based compensation expense, $1.7 million in non-cash interest income on the liability related to the royalty monetization and $1.0 million in depreciation expense. The net change in our operating assets and liabilities included a $1.8 million decrease in accrued liabilities, a $2.9 million decrease in deferred revenue and a $0.7 million increase in accounts payable.
Cash Flows from Investing Activities
Our investing activities have consisted primarily of our capital expenditures and purchases and sales and maturities of our available-for-sale investments.
During the six months ended June 30, 2021, cash used in investing activities of $15.0 million was primarily the net result of $38.2 million for purchases of investments and $1.6 million for purchases of property and equipment, partially offset by $24.8 million in proceeds from maturity of investments. During the six months ended June 30, 2020, cash provided by investing activities of $29.6 million was the net result of $58.6 million in proceeds from maturity of investments, offset by $28.8 million for purchases of investments and purchases of property and equipment of $0.2 million.
Cash Flows from Financing Activities
Cash flows from financing activities primarily reflect proceeds from the sale of our securities and payments made on debt financings.
During the six months ended June 30, 2021, cash provided by financing activities of $32.1 million was primarily due to $36.4 million in net proceeds received in connection with equity financings, partially offset by $4.2 million used for payment of long-term debt. During the six months ended June 30, 2020, cash provided by financing activities was primarily due to $1.4 million in net proceeds received under the ATM Agreement and $0.2 million in proceeds as a result of stock purchases made under our Amended 2011 ESPP, partially offset by $0.1 million used for payment of employee tax obligations relating to the vesting of restricted stock units.
Operating Capital and Capital Expenditure Requirements
Our current operating plan includes expenditures related to the continued launch of DSUVIA in the United States. This plan includes an assumption that COVID-19 related restrictions will not increase considerably, and includes anticipated activities required to resubmit the Zalviso NDA. These assumptions may change as a result of many factors. We will continue to evaluate the work necessary to successfully launch DSUVIA and gain approval of our product candidates in the United States and intend to update our cash forecasts accordingly. Our forecast that our existing capital resources will permit us to meet our capital and operational requirements through at least the next twelve months is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.
Our future capital requirements may vary materially from our expectations based on numerous factors, including, but not limited to, the following:
| • |
the impact and timing of COVID-19 on our operations, our sales representatives’ access to hospitals or other healthcare facilities, and our level of sales; |
| • |
expenditures related to the launch of DSUVIA and potential commercialization of our product candidates, if approved; |
| • |
future manufacturing, selling and marketing costs related to DSUVIA and our product candidates, if approved, including our contractual obligations to Aguettant under the DZUVEO Agreement; |
| • |
costs associated with business development activities and licensing transactions; |
| • |
the outcome, timing and cost of the regulatory submissions for our product candidates and any approvals for our product candidates; |
| • |
the initiation, progress, timing and completion of any post-approval clinical trials for DSUVIA, or our product candidates, if approved; |
| • |
changes in the focus and direction of our business strategy and/or research and development programs; |
| • |
milestone and royalty revenue we receive under our collaborative development and commercialization arrangements, including the DZUVEO Agreement; |
| • |
delays that may be caused by changing regulatory requirements; |
| • |
the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims; |
| • |
the timing and terms of future in-licensing and out-licensing transactions; |
| • |
the cost and timing of establishing sales, marketing, manufacturing and distribution capabilities; |
| • |
the cost of procuring clinical and commercial supplies of DSUVIA and our product candidates, if approved; |
| • |
the extent to which we acquire or invest in businesses, products and product candidates or technologies; and |
| • |
the expenses associated with litigation. |
In the long-term, our existing capital resources will not be sufficient to fund our operations until such time as we may be able to generate sufficient revenues to sustain our operations. We will have to raise additional funds through the sale of our equity securities, monetization of current and future assets, issuance of debt or debt-like securities or from development and licensing arrangements to sustain our operations and continue our development programs.
Please see “Part II., Item 1A. Risk Factors—Risks Related to Our Financial Condition and Need for Additional Capital.”
Off-Balance Sheet Arrangements
Through June 30, 2021, we have not entered into any off-balance sheet arrangements and do not have any holdings in variable interest entities.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and are not required to provide the information specified under this item.
Item 4. Controls and Procedures
We maintain disclosure controls and procedures (as defined in Exchange Act Rule 13a–15(e) and 15d-15(e)) that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Evaluation of disclosure controls and procedures. As required by Rule 13a-15(b) under the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in internal control over financial reporting. There have been no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
From time to time we may be involved in legal proceedings relating to intellectual property, commercial, employment and other matters arising in the ordinary course of business. Such matters are subject to uncertainty and there can be no assurance that such legal proceedings will not have a material adverse effect on our business, results of operations, financial position or cash flows. Other than the following, we believe there are no legal proceedings pending that could, individually or in the aggregate, have a material adverse effect on our results of operations or financial condition:
On June 8, 2021, a securities class action complaint was filed in the U.S. District Court for the Northern District of California against us and two of our officers. The plaintiff is a purported stockholder of the Company. The complaint alleges that defendants violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by making false and misleading statements and omissions of material fact about our disclosure controls and procedures with respect to our marketing of DSUVIA. The complaint seeks unspecified damages, interest, attorneys’ fees, and other costs. Motions for appointment of lead plaintiff under the Private Securities Litigation Reform Act were filed on August 9, 2021 and a hearing on the motions has been noticed for December 16, 2021. Please see “Item 1A. Risk Factors—Risks of a General Nature -- Our involvement in securities-related class action litigation could divert our resources and management's attention and harm our business.”
On July 6, 2021, a purported shareholder derivative complaint was filed in the U.S. District Court for the Northern District of California. The complaint names ten of our officers and directors and asserts state and federal claims based on the same alleged misstatements as the shareholder class action complaint. The complaint seeks unspecified damages, attorneys’ fees, and other costs. Please see “Item 1A. Risk Factors—Risks of a General Nature—Litigation may substantially increase our costs and harm our business.”
We believe that these lawsuits are without merit, and we intend to vigorously defend against them. Given the uncertainty of litigation, the preliminary stage of the cases, and the legal standards that must be met for, among other things, class certification and success on the merits, we cannot estimate the reasonably possible loss or range of loss that may result from these actions.
Item 1A. Risk Factors
This Quarterly Report on Form 10-Q contains forward-looking information based on our current expectations. Because our actual results may differ materially from any forward-looking statements made by or on behalf of us, this section includes a discussion of important factors that could affect our actual future results, including, but not limited to, our revenues, expenses, net loss and loss per share. You should carefully consider these risk factors, together with all of the other information included in this Quarterly Report on Form 10-Q as well as our other publicly available filings with the U.S. Securities and Exchange Commission, or SEC.
Summary Risk Factors
Our business is subject to numerous risks, as more fully described in this section below this summary. You should read these risks before you invest in our common stock. We may be unable, for many reasons, including those that are beyond our control, to implement our business strategy. In particular, our risks include:
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Our business is being adversely impacted by the COVID-19 pandemic. |
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We have incurred significant losses since our inception, anticipate that we will continue to incur significant losses in 2021 and may continue to incur losses in the future. |
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We have not yet generated significant product revenue and may never be profitable. |
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We will require additional capital and may be unable to raise capital, which would force us to delay, reduce or eliminate our commercialization efforts and product development programs and could cause us to cease operations. |
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Positive clinical results obtained to date for Zalviso may be disputed in FDA review, do not guarantee regulatory approval and may not be obtained from future clinical trials. |
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Existing and future legislation may increase the difficulty and cost for us to commercialize our products and affect the prices we may obtain. |
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Guidelines and recommendations published by government agencies, as well as non-governmental organizations, and existing laws and regulations can reduce the use of DSUVIA, and Zalviso, if approved in the United States. |
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Zalviso may cause adverse effects or have other properties that could delay or prevent regulatory approval or limit the scope of any approved label or market acceptance. DSUVIA may cause adverse effects or have other properties that could limit market acceptance. |
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Although we have obtained regulatory approval for DSUVIA, and even if we obtain regulatory approval for Zalviso in the United States, we and our collaborators face extensive regulatory requirements and our products may face future development and regulatory difficulties. |
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The commercial success of DSUVIA and Zalviso, if approved, in the United States, as well as DZUVEO and Zalviso in Europe, will depend upon the acceptance of these products by the medical community, including physicians, nurses, patients, and pharmacy and therapeutics committees. |
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If we are unable to maintain or grow our sales and marketing capabilities or enter into agreements with third parties to market and sell our products, we may be unable to generate sufficient product revenue. |
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A key part of our business strategy is to establish collaborative relationships to commercialize and fund development and approval of our products, particularly outside of the United States. We may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and commercialize our products successfully, if at all. |
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If we cannot defend our issued patents from third party claims or if our pending patent applications fail to issue, our business could be adversely affected.</ |