Welcome to the AcelRx Fourth Quarter and Full Year 2017 Conference Call. This call is being webcast live on the event stage of the Investor section of AcelRx’s website at acelrx.com. This call is the property of AcelRx and any recording, reproduction or transmission of this call without the express written consent of AcelRx is strictly prohibited. As a reminder, today’s call is being recorded. You may listen to the webcast replay of this call by going to the investor section of AcelRx’s website. I would now like to turn the conference over to Raffi Asadorian, Chief Financial Officer. Please go ahead.

Thank you for joining us this afternoon. Today, we reported our fourth quarter and full year 2017 financial results in our press release. Separately, we also reported the receipt of the official FDA minutes from the Type A meeting held in January. The releases and the slide presentation accompanying this call are available in the Investor section of our website. With me today are Vince Angotti, our Chief Executive Officer; and Pam Palmer, our Chief Medical Officer. During this call, we will make forward-looking statements about events and circumstances that have no yet occurred, including but not limited to the process and timing of anticipated future development of DSUVIA, known as DZUVEO outside the United States, and ZALVISO, including AcelRx’s plans for resubmission of DSUVIA and ZALVISO NDA to gain approval in the U.S. The scientific review and approval of the Marketing Authorization Application with the European Medicines Agency of DSUVIA, the therapeutics and commercial potential of AcelRx’s product candidates including potential market opportunities for DSUVIA, DZUVEO and ZALVISO. And the company’s ability to continue its cash management plan to maintain a solid liquidity position and financial flexibility and its projected cash flows. These statements are based on management’s current expectation and inherently involve significant risks and uncertainties. Actual results and timing of these events could differ materially from those anticipated in such forward-looking statements. And as a result of these risks and uncertainties, which include without limitation, risks related to AcelRx’s product development programs and outcomes of any regulatory reviews, the possibility that regulatory agencies could dispute or interpret differently the results of AcelRx’s clinical trials, the accuracy of AcelRx’s estimates regarding expenses, capital requirements and the need for financing and other risks including those detailed in the company’s recent SEC filings and the Risk Factor section of its quarterly report on Form 10-Q filed on November 9, 2017 and our year ended December 31, 2017 on Form 10-K which we will file shortly. AcelRx disclaims any obligation to update information contained in these forward-looking statements whether as a result of new information, future events or otherwise. Please refer to the AcelRx SEC filings for a detailed discussion on the relevant risks and uncertainties. I’ll now turn the call over to Vince Angotti. Vince.

Thank you, Raffi. Good afternoon everyone and thank you for joining us today. We're pleased to begin 2018 with positive momentum coming out of what we believe was a productive Type A meeting in January and one which puts us back on a planned path to resubmit the DSUVIA NDA in the second quarter of this year. On the call today, I’ll cover three primary topics. First, the outcome of the January Type A meeting; second, the expected regulatory timeline for DSUVIA and other product candidates, which includes many key near-term milestones; and third, an update on our financials and 2018 outlook. But before jumping in I want to highlight that in addition to the progress on the regulatory front, we continue to maintain our financial discipline during the quarter and ended 2017 with $60.5 million in cash and investments. Raffi will provide further details later on this call, but I commend the team for maintaining a prudent approach on spending while still addressing our key priority of preparing for a potential DSUVIA approval and commercial launch. Now moving to the first topic, the outcome of the Type A FDA meeting. Our team has been diligently working on an expeditious path forward since we’ve received a complete response letter, or CRL, regarding our DSUVIA NDA in October of 2017. The two primary points from the FDA in the CRL we’re number one although the safety database was suitable in the number of patients. They asked us to collect additional data in 50 patients with post-operative pain sufficient to evaluate the safety of DSUVIA at the maximum daily dose in the proposed label. And two, the second point. Modify the directions for use, or DFU, to mitigate the risk of misplaced tablets and then validate the effectiveness of these changes in…

Thanks, Vince, and good afternoon everyone. Fourth quarter much like the last quarter was managed conservatively from a financial perspective, as we continue to hold on ramping up commercial resources prior to a potential PDUFA date for DSUVIA. We will continue to manage our cash prudently to ensure we have adequate financial resources as we focus on obtaining approval for our product candidates. Our full year 2017 revenues were $8 million, which consisted of $7.1 million in revenue under our collaboration agreement with Grünenthal and the remainder relating to our Department of Defense contract for DSUVIA development. The total revenue decline of $9.4 million from the full year 2016 was attributed mainly to lower invoicing under our DSUVIA contract with the Department of Defense as there was reduced DSUVIA development related work and costs in 2017. To date we have recognized a total of $22 million in revenue under DoD grants and contracts and have agreed on an additional $500,000 for new DSUVIA development costs incurred or expected to be incurred in 2018. Looking forward, Grünenthal’s positive sales growth trend will not always closely aligned with the timing of our product sales as Grünenthal’s sells down its existing inventories. Therefore, despite Grünenthal’s continued growth expectations for ZALVISO in 2018, we expect our collaboration revenues to decline this year before an anticipated increase in 2019. As a reminder, these collaboration revenues are not expected to have a significant impact on our cash flows in the near-term since a significant portion of European ZALVISO royalties and milestones were already monetized with PDL in 2015. We ended the year with $60.5 million in cash and investments, which was a decline of $7.4 million from Q3 2017. The decline was mainly driven by our cash operating expenses plus $4 million of debt service on…

Thanks, Raffi. We’re also pleased to be participating at several upcoming investor conferences. We’ll be presenting this month at the ROTH Conference, Cowen Healthcare Conference and the Oppenheimer Healthcare Conference. We’re optimistic about the upcoming milestones with an expected DSUVIA NDA resubmission in the near-term and PDUFA date later this year. We remain focused on completing the necessary steps to get the NDA resubmitted in Q2 specifically initiating and completing the HF study and we intend to keep the positive momentum to look forward to updating you throughout 2018. With that said I would now like to open the line up for any questions you may have. Operator?

We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Matthew Andrews with Jefferies. Please go ahead.

Hey, good afternoon. Thanks for the chance to ask some questions. Vince, can you – what does the adjective reasonable mean? Is that language that the FDA used? And if so, how would your advisors describe what that means?

Yeah, we were very careful about the selection of the language, Matt, as you can imagine and reasonable was language that they use in response to our discussion and our advisors felt that that was a positive outcome related to the answer to that question.

And is it a term that they've seen before in discussions with FDA in terms of meeting minutes?

I can't comment on that in meeting minutes, but we can tell you it was an accurate reflection of the discussion we had with them and – that our advisors were comfortable with that language.

And then as it relates to the expected FDA ad com, did they specifically communicate that to you or are you just being proactive in preparing for that type of event?

No we asked them actually in the submission of the briefing book prior to the actual FDA Type A meeting whether we should expect an ad com and they said yes and that the timing of that ad com will be communicated to us after receipt of the resubmission.

Gotcha. And then lastly, can you talk about your thoughts relative to how the commercial opportunity may be impacted with this potential labeling language in terms of the lower maximum dosage? Do you think it restricts the opportunity for you assuming the products approved? Thanks.

Yeah, so, we do not. When we consider modeling moving forward, we're clearly not modeling doses of the 24 tablets on average per day. So we don't believe it affects our commercial potential of this product whatsoever. I'll remind you that the DSUVIA market is significant as we've communicated previously. It target patient market of around 92 million in the U.S. alone. And again, we're focusing on two particular areas in that market. Our initial target for DSUVIA is in the emergency department where we estimated 18 million patients are receiving an IV for pain only. And certainly their doses wouldn't be very high. It’s a simple efficient replacement for these ER nurses and doctors, let alone it’s a non-invasive delivery system that's a benefit to the patients. In addition to the emergency room, we're targeting outpatient surgery. We believe the profile of DSUVIA fits well the needs of the hospital, quickly move patients to discharge and we estimate about $11 million outpatient surgery patients suffering from moderate-to-severe acute pain. So, again, markets are very sizable. And with the reduction in dosing from 24 to 12, we don't believe it any effect on our commercial potential moving forward.

Okay, thank you.

You're welcome, Matt.

[Operator Instructions] And there appears to be no further questions. I would like to turn the conference back over to Vince Angotti for any closing remarks.

Thank you, operator. And now, we're clearly excited about the progress we've made on the regulatory front both from the DSUVIA perspective in the U.S. as well as the DZUVEO perspective in Europe. We'd like to thank everyone for joining us on the call today and for you continued support of AcelRx. We look forward to updating you on our continued progress with our upcoming milestones, which are many in 2018. Thank you.

This conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.