News Release
View printer-friendly version << Back
AcelRx Pharmaceuticals Reports Second Quarter 2014 Financial Results
"We were disappointed with the receipt of a Complete Response Letter for Zalviso and we look forward to meeting with the
The CRL contains requests for additional information on the Zalviso System to ensure proper use of the device. The requests include submission of data demonstrating a reduction in the incidence of optical system errors, changes to the Instructions for Use for the device to address inadvertent dosing, among other items, and submission of additional data to support the shelf life of the product. We believe certain of these requests have been addressed in amendments to the NDA that were submitted prior to the receipt of the CRL but, as acknowledged by the
Second Quarter Financial Results
Net loss for the second quarter of 2014 was
The decrease in the net loss was primarily due to the valuation of PIPE warrants, fluctuations for which are charged as other income or expense, partially offset by an increase in operating expenses.
During the second quarter of 2014, AcelRx recognized
Research and development expenses for the quarter ended
General and administrative expenses were
As discussed above, other income and expense in the second quarter of 2014 includes
Year-to-Date Financial Results
For the six months ended
Research and development expenses for the six months ended
As of
Financial Outlook
We reiterate and issue financial guidance for the year, as follows:
- Research and development expenses are expected to be in the range of
$27 to $29 million for the year and relatively flat quarter over quarter. - General and administrative expenses, including pre-commercialization expenses, are expected to be in the range of
$21 to $23 million for the year and relatively flat quarter over quarter. - Total operating expenses for 2014 are anticipated to be in the range of
$48 to $52 million . - Estimated cash, cash equivalents and investment balances at
December 31, 2014 of at least$65 million .
Corporate Update and Review of Recent Accomplishments
- On
July 7, 2014 , and pursuant to the license and supply agreement withGrunenthal Group ,AcelRx and Grunenthal Group announced that Grunenthal submitted a Marketing Authorization Application (MAA) to theEuropean Medicines Authority for Zalviso for the management of moderate-to-severe acute pain in adult patients in a medically supervised environment. Under the terms of the license agreement, AcelRx will receive a cash payment of$5 million for the MAA submission in the third quarter of 2014. AcelRx is eligible to receive an additional$15 million milestone payment upon the approval of the MAA. After approval by EMA, AcelRx is eligible to receive approximately$200 million in additional milestone payments, based upon successful regulatory and product development efforts ($28.5 million ) and net sales target achievements ($171.5 million ). Grunenthal will also make tiered royalty, supply and trademark fee payments in the mid-teens up to the twenty percent range, on net sales of Zalviso in the Grunenthal territory (EU,Australia and certain other countries). - In
June 2014 , AcelRx completed a pharmacokinetic study in support of the ARX-04 development program. In this study of healthy volunteers, it was shown that two sublingual administrations of a Zalviso 15mcg sufentanil tablet dosed 20 minutes apart were equivalent to one sublingual administration of an ARX-04 30mcg sufentanil tablet. The significance of this study is that we believe we can include approximately 300 patients from the Zalviso clinical program in the ARX-04 safety database. The ARX-04 safety database required by theFDA is 500 patients and, therefore, we believe this demonstration of dose equivalency will allow for a significant reduction in the number of patients necessary to enroll in the ARX-04 Phase 3 clinical program. We intend to initiate our Phase 3 clinical study for ARX-04 before the end of 2014.
Conference Call
AcelRx will conduct a conference call and webcast today,
About Zalviso™
Zalviso is an investigational pre-programmed, non-invasive system to allow hospital patients with moderate-to-severe acute pain to self-dose with sublingual sufentanil tablets to manage their pain. Zalviso consists of sufentanil tablets delivered by the Zalviso System, a needle-free, handheld, patient-administered, pain management system (together, "Zalviso"). Zalviso is designed to help address certain problems associated with post-operative intravenous patient-controlled analgesia, by offering:
- A high therapeutic index opioid: Zalviso uses sufentanil, an opioid that has a high therapeutic index. The therapeutic index is the ratio of the effective dose versus the lethal or toxic dose. In animal studies, the therapeutic index for sufentanil was approximately 100 times larger than fentanyl and 300 times larger than morphine.
- A non-invasive route of delivery: Zalviso utilizes a sufentanil tablet which allows for a sublingual (under the tongue) route of delivery. Sufentanil is highly lipophilic which provides for rapid absorption in the fatty cells (or mucosal tissue) found under the tongue and for rapid transit across the blood-brain barrier to bind the mu-opioid receptors in the brain. The sublingual delivery used by Zalviso provides rapid onset of analgesia. The sublingual delivery system also eliminates the risk of IV-related analgesic gaps and IV complications, such as catheter-related infections. In addition, because patients do not require direct connection to an IV PCA infusion pump through IV tubing, Zalviso allows for ease of patient mobility.
- A pre-programmed PCA solution: Zalviso allows patients to self-dose sufentanil sublingual tablets via a pre-programmed, secure system designed to eliminate the risk of programming errors.
About
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the Company's Zalviso NDA and the Complete Response Letter (CRL), our plans to address the issues raised in the CRL, our anticipated resubmission of the Zalviso NDA to the
Selected Financial Data |
|||||||
(in thousands, except per share data) |
|||||||
(unaudited) |
|||||||
Three Months Ended |
Six Months Ended |
||||||
June 30, |
June 30, |
||||||
2014 |
2013 |
2014 |
2013 |
||||
Statement of Comprehensive Loss Data |
|||||||
Revenue: |
|||||||
Collaboration agreement |
$ 71 |
$ - |
$ 166 |
$ - |
|||
Research grant |
- |
407 |
- |
1,347 |
|||
Total revenue |
71 |
407 |
166 |
1,347 |
|||
Operating expenses: |
|||||||
Research and development (1) |
7,284 |
6,108 |
11,995 |
15,426 |
|||
General and administrative (1) |
5,047 |
2,070 |
8,972 |
4,261 |
|||
Total operating expenses |
12,331 |
8,178 |
20,967 |
19,687 |
|||
Loss from operations |
(12,260) |
(7,771) |
(20,801) |
(18,340) |
|||
Interest expense |
(530) |
(403) |
(1,002) |
(857) |
|||
Interest income and other income (expense), net(2) |
2,215 |
(9,273) |
1,597 |
(11,012) |
|||
Net loss |
$ (10,575) |
$ (17,447) |
$(20,206) |
$(30,209) |
|||
Basic net loss per common share |
$ (0.24) |
$ (0.47) |
$ (0.47) |
$ (0.81) |
|||
Shares used in computing basic net loss per common share |
43,333 |
37,262 |
43,262 |
37,198 |
|||
Diluted net loss per common share |
$ (0.30) |
$ (0.47) |
$ (0.50) |
$ (0.81) |
|||
Shares used in computing diluted net loss per common share |
44,310 |
37,262 |
43,774 |
37,198 |
|||
(1) Includes the following non-cash, stock-based compensation expense: |
|||||||
Research and development |
$ 560 |
$ 411 |
$ 1,039 |
$ 766 |
|||
General and administrative |
334 |
391 |
830 |
793 |
|||
Total |
$ 894 |
$ 802 |
$ 1,869 |
$ 1,559 |
|||
(2) Interest income and other income (expense) includes $2.5 million and $1.8 million in non-cash income for the three and six months ended June 30, 2014, respectively, and $8.7 million and $10.4 million in non-cash charges during the three and six months ended June 30, 2013, respectively, related to warrants issued in connection with a private placement equity financing, completed in June 2012. |
|||||||
June 30, 2014 |
December 31, 2013 |
||||||
Selected Balance Sheet Data |
|||||||
Cash, cash equivalents and investments |
$ 92,349 |
$ 103,663 |
|||||
Total assets |
100,374 |
110,031 |
|||||
Total liabilities |
44,825 |
36,872 |
|||||
Total stockholders' equity |
55,549 |
73,159 |
Logo - http://photos.prnewswire.com/prnh/20130226/MM67303LOGO
SOURCE
Timothy E. Morris, Chief Financial Officer, 650.216.3511, tmorris@acelrx.com; or Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com