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AcelRx Pharmaceuticals Reports Second Quarter 2020 Financial Results
"Despite the challenges with COVID in the second quarter, we made meaningful progress towards generating long-term shareholder value and expanding the DSUVIA launch through advancements with the
Second Quarter and Recent Highlights
- DSUVIA achieved Milestone C approval from the
Department of Defense , a decision that approves DSUVIA for use in allU.S. Army sets, kits and outfits (SKOs). AcelRx expects that initial stocking orders beginning later this year forU.S. Army SKOs alone will approximate$30 million over the next three years, dependent on troop deployment schedules. - The
DoD issued a Notice of Intent, converting to a Request for Proposal (RFP), for the purchase of up to 12,200 boxes or 122,000 DSUVIA units, expected to be ordered in the third quarter of 2020, which is separate from expected purchases for SKOs. - In July, AcelRx entered into a distribution agreement with Zimmer Biomet to market DSUVIA® (sufentanil sublingual tablet), 30 mcg, within the dental and oral surgery markets in
the United States exclusively through Zimmer Biomet's Dental division, expandingU.S. availability of DSUVIA. It is estimated that the applicable market in dental surgeries is over 7 million annual procedures. - In July, AcelRx completed a
$10 million common stock offering priced at the market with two leading life science investors.
Financial Information
- As previously announced:
- Cash, cash equivalents and short-term investments balance of
$43.7 million as ofJune 30, 2020 ; - Second quarter 2020 net revenues were
$2.9 million , of which approximately$2.6 million relates to the recognition of revenue related to the Company's Zalviso® agreement with Grünenthal that was previously deferred; - Combined R&D and SG&A expenses for the second quarter of 2020 totaled
$8.4 million compared to$12.5 million for the second quarter of 2019. Excluding stock-based compensation expense, these amounts were$7.3 million for the second quarter of 2020 compared to$11.2 million for the second quarter of 2019. R&D and SG&A expenses for the first half of 2020 totaled$23.1 million compared to$23.8 million in the first half of 2019. Excluding stock-based compensation expense, these figures were$20.9 million for the first half of 2020 compared to$21.5 million for the first half of 2019. The decrease in combined R&D and SG&A expenses in the second quarter of 2020 was primarily due to a reduction of$1.9 million in DSUVIA-related commercialization expenses, a$1.7 million reduction in personnel costs, and a net benefit of$0.5 million from the receipt of a breakup fee from Tetraphase, net of expenses incurred related to the transaction in the quarter. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures. - For the second quarter of 2020, net loss was
$6.6 million , or$0.08 per basic and diluted share, compared to$12.4 million , or$0.16 per basic and diluted share, for the second quarter of 2019. Net loss for the first half of 2020 was$22.5 million , or$0.28 basic and diluted net loss per share, compared to$26.1 million , or$0.33 basic and diluted net loss per share, for the prior year period.
Webcast and Conference Call Information
As previously announced, AcelRx will host a live webcast
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO™ in
This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.
About
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
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to near-term revenue drivers, the expected impact of recent hospital system wins on revenue and the timing of such impact, the timing and size of military orders and the ongoing effects of the COVID-19 pandemic and its anticipated impacts on AcelRx's business. 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. 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 the risk that the military and hospital systems delay, or fail to place, orders, that AcelRx may not experience the expected benefits from the Zimmer Biomet commercial opportunity or that the impacts AcelRx is experiencing from the ongoing COVID-19 pandemic may be prolonged or exacerbated. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described 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
Media Contacts |
Investor Contacts |
Evoke |
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215-928-2748 / 215-928-2346 |
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646-378-2923 |
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Selected Financial Data |
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(in thousands, except per share data) |
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(unaudited) |
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Three Months Ended |
Six Months Ended |
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June 30 |
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2020 |
2019 |
2020 |
2019 |
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Statement of Comprehensive Loss Data |
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Revenue: |
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Product sales |
$ 303 |
$ 768 |
$ 577 |
$ 894 |
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Contract and other collaboration |
2,621 |
173 |
2,733 |
312 |
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Total revenue |
2,924 |
941 |
3,310 |
1,206 |
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Operating costs and expenses: |
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Cost of goods sold (1) |
1,370 |
1,810 |
2,881 |
3,040 |
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Research and development (1) |
813 |
1,163 |
2,225 |
2,540 |
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Selling, general and administrative (1) |
7,575 |
11,329 |
20,886 |
21,305 |
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Total operating costs and expenses |
9,758 |
14,302 |
25,992 |
26,885 |
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Loss from operations |
(6,834) |
(13,361) |
(22,682) |
(25,679) |
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Other income (expense): |
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Interest expense |
(872) |
(500) |
(1,727) |
(876) |
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Interest income and other income (expense), net |
270 |
456 |
205 |
1,083 |
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Non-cash interest income (expense) on liability related to sale of future royalties |
834 |
996 |
1,677 |
(611) |
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Total other income (expense) |
232 |
952 |
155 |
(404) |
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Provision for income taxes |
(4) |
(3) |
(4) |
(3) |
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Net loss |
$ (6,606) |
$ (12,412) |
$ (22,531) |
$ (26,086) |
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Basic and diluted net loss per common share |
$ (0.08) |
$ (0.16) |
$ (0.28) |
$ (0.33) |
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Shares used in computing basic and diluted net loss per common share |
80,662 |
78,902 |
80,360 |
78,846 |
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(1) Includes the following non-cash, stock-based compensation expense: |
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Cost of goods sold |
$ 27 |
$ 68 |
$ 73 |
$ 129 |
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Research and development |
184 |
233 |
384 |
457 |
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Selling, general and administrative |
879 |
1,045 |
1,779 |
1,867 |
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Total |
$ 1,090 |
$ 1,346 |
$ 2,236 |
$ 2,453 |
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Selected Balance Sheet Data |
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Cash, cash equivalents and investments |
$ 43,686 |
$ 66,137 |
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Total assets |
67,400 |
91,356 |
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Total liabilities |
127,532 |
132,774 |
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Total stockholders' (deficit) equity |
(60,132) |
(41,418) |
Reconciliation of Non-GAAP Financial Measures |
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(Operating Expenses less associated stock-based compensation expense) |
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Three Months Ended |
Six Months Ended |
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2020 |
2019 |
2019 |
2018 |
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Operating expenses (GAAP): |
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Research and development |
$ 813 |
$ 1,163 |
$ 2,225 |
$ 2,540 |
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Selling, general and administrative |
7,575 |
11,329 |
20,886 |
21,305 |
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Total operating expenses |
8,388 |
12,492 |
23,111 |
23,845 |
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Less associated stock-based |
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compensation expense |
1,063 |
1,278 |
2,163 |
2,324 |
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Operating expenses (non-GAAP) |
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