View:

Download DOC

Download PDF

Download XLS

Download XBRL

Exhibit 99.1

AcelRx Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results

AcelRx expanded late-stage pipeline with Niyad™ (nafamostat), which has received Breakthrough Designation status from the FDA and an ICD-10 procedural code from CMS

Q4 2021 DSUVIA unit sales growth of 142% compared to Q3 2021

AcelRx had $51.6 million of cash and short-term investments as of December 31, 2021

HAYWARD, Calif., March 10, 2022 – AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported its fourth quarter and full year 2021 financial results.

“We are executing on our strategy to expand and diversify our product portfolio by acquiring commercial-ready, or late-stage development-ready assets that address what we consider as unmet market needs for medically supervised settings. In particular, we are currently focused on the development and ultimate approval of our newly secured pre-filled syringes and Niyad (nafamostat) product candidates which could potentially provide multiple value creating catalysts for our shareholders in the near-term,” said Vince Angotti, Chief Executive Officer of AcelRx. Mr. Angotti continued, “In addition, we have taken deliberate actions to adapt to the evolving healthcare environment as many medical procedures resulting in moderate-to-severe pain that were previously performed in surgical centers or hospitals have now been shifted to procedural suites, allowing us the opportunity to introduce DSUVIA into these settings. We have thus shifted our commercial resources, beginning in the third quarter, to focus on this new customer base, resulting in solid growth in DSUVIA unit sales in the fourth quarter 2021.”

FY 2021 and Recent Highlights

Financial Information

2022 Guidance

The Company’s 2022 year-end goals include the submission of two NDAs for its pre-filled syringe product candidates, pending outcome of FDA feedback that is expected in the second quarter, and the manufacturing of initial lots of nafamostat. Quarterly combined R&D and SG&A expense is expected to be approximately $9-$10 million (and $8-$9 million excluding stock compensation and depreciation). Annual debt service is expected to approximate $10 million as the Company continues to pay down amounts outstanding under its senior debt facility that matures in June 2023. Annual capital expenditures are expected to approximate $2 million attributed mainly to the final validation of the automated packaging line at AcelRx’s contract manufacturer. 

2022 financial guidance is based on the Company's current expectations and are forward-looking statements. Actual results could differ materially depending on market conditions and the factors set forth under Forward-Looking Statements below.

Webcast and Conference Call Information

As previously announced, AcelRx will host a live webcast Thursday, March 10th at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of AcelRx's website at http://ir.acelrx.com/ and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of AcelRx’s website at http://ir.acelrx.com/.

About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, to be marketed as DZUVEO® in Europe, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route of administration and to eliminate dosing errors associated with intravenous (IV) administration of opioid analgesics. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for 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. The European Commission approved DZUVEO for marketing in Europe and it will be commercialized by AcelRx's European partner, Aguettant.

For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

About nafamostat
Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit. Niyad has received Breakthrough Device Designation Status from the FDA. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that we plan to potentially develop as a COVID anti-viral treatment, as well as for the treatment of disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis.

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and has several product candidates in its portfolio. These product candidates include Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S. being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings, two pre-filled, ready-to-use syringes of ephedrine and phenylephrine licensed for the U.S. market from Aguettant, Niyad™, a regional anticoagulant for the extracorporeal circuit, and LTX-608, for the potential treatment of COVID-19, disseminated intravascular coagulation, acute respiratory distress syndrome and acute pancreatitis. DZUVEO and Zalviso are both approved products in Europe.

This release is intended for investors only. For additional information about AcelRx, please visit www.acelrx.com.

Non-GAAP Financial Measures
To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), AcelRx uses certain non-GAAP financial measures in this press release, in particular, excluding non-cash depreciation and stock-based compensation expense from its operating expenses. AcelRx believes that these non-GAAP financial measures provide useful supplementary information to, and facilitate additional analysis by, investors and analysts. In particular, AcelRx believes that these non-GAAP financial measures, when considered together with AcelRx's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare AcelRx's results from period to period and to its forward-looking guidance. In addition, these types of non-GAAP financial measures are regularly used by investors and analysts to model and track AcelRx's financial performance. AcelRx's management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate AcelRx's business and to make operating decisions. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the expected benefits arising from our recent acquisition of Lowell, expected areas of growth for DSUVIA, the expected launch of DZUVEO in Europe by Aguettant and the expected license consideration arising from such commercialization activities, the expected market opportunity for our new product candidates in-licensed from Aguettant and/or acquired through the Lowell acquisition, our plans to file NDAs for our new product candidates and the timing of such filings. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) the risk that the acquisition of Lowell disrupts the current plans and operations of AcelRx and could adversely affect its business and the price of AcelRx’s common stock; (ii) risks relating to our ability to successfully market DSUVIA in existing and in new and untested markets; (iii) risks relating to the ability of Aguettant to successfully launch and commercialize DZUVEO in the European marketplace and our attendant ability to realize licensing revenues that are contingent on such success; (iv) risks relating to our ability to obtain regulatory approvals for the pre-filled syringe product candidates in-licensed from Aguettant; (v) risks relating to our ability to successfully commercialize the pre-filled syringe product candidates in-licensed from Aguettant should we obtain regulatory approvals; (vi) risks relating to our ability to obtain regulatory approvals for the nafamostat product candidates acquired from Lowell; (vii) risks relating to our ability to successfully commercialize the nafamostat product candidates acquired from Lowell should we obtain regulatory approvals; (viii) risks relating to AcelRx’s product development activities diverting AcelRx management's attention from ongoing commercial business operations; (ix) risks related to the ability of AcelRx to implement its plans, forecasts and other business expectations; (x) risks related to obtaining final validation and regulatory approval of our fully automated packaging line; and (xi) risks related to unexpected variations in market growth and demand for AcelRx's commercial and developmental products and technologies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC) and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx's most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

###

Reconciliation of Non-GAAP Financial Measures
(Operating Expenses less associated stock-based compensation expense)