On August 5, 2019 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, reported its second quarter 2019 financial results (Press release, AcelRx Pharmaceuticals, AUG 5, 2019, View Source [SID1234538150]).
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"We successfully executed our first full quarter of launch with only 15 hospital account managers focused on gaining early approval for use of DSUVIA, leading to 51 REMS-certified facilities to date," said Vince Angotti, Chief Executive Officer of AcelRx. "The widespread appreciation of DSUVIA’s unique pharmacokinetic profile and route of administration is evident in the diversity of REMS-certified facilities such as hospitals, ambulatory surgical centers, and procedural centers including orthopedic, vascular, plastic surgery and wound care. We have strong momentum heading into the second half of the year, particularly now that we have our commercial organization at full strength with 40 hospital account managers," continued Angotti.
Second Quarter and Recent Highlights
51 REMS-certified healthcare facilities now approved to purchase and use DSUVIA within their healthcare settings, two-thirds of which occurred since June 15; 43 formulary approvals achieved since launch
Completed the second phase of commercial team hiring effective July 1, as planned, increasing the number of hospital account managers from 15 to 40; the balance of the commercial launch organization now also includes 7 market access personnel and 7 medical science liaisons in place to educate healthcare professionals on the benefits of DSUVIA for their patients and their institutions
Refinanced previously existing senior secured debt facility in the amount of $25.0 million, providing the Company with a lower cost of capital, lower debt service, and $15.9 million in net proceeds after the $8.9 million repayment of its outstanding obligations
Added as a member of the Russell 2000 and Russell 3000 Indexes effective July 1, 2019
Financial Information
Cash, cash equivalents and short-term investments balance of $91.5 million as of June 30, 2019;
Combined R&D and SG&A expenses for the second quarter of 2019 totaled $12.5 million compared to $7.2 million for the second quarter of 2018. Excluding stock-based compensation expense, these amounts were $11.2 million for the second quarter of 2019 compared to $6.2 million for the second quarter of 2018. R&D and G&A expenses for the first half of 2019 totaled $23.8 million compared to $14.7 million in the first half of 2018. Excluding stock-based compensation expense, these figures were $21.5 million for the first half of 2019 compared to $12.8 million for the first half of 2018. The increase in R&D and SG&A expenses is primarily due to increased personnel-related expenses for the commercial launch of DSUVIA. 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;
Net cash outflow for the second quarter of 2019 was $14.6 million, not including the $15.9 million in net proceeds from the refinancing of our senior secured debt which included $1.8 million in debt service;
For the second quarter of 2019, net loss was $12.4 million, or $0.16 per basic and diluted share, compared to $10.5 million, or $0.20 per basic and diluted share, for the second quarter of 2018. Net loss for the first half of 2019 was $26.1 million, or $0.33 basic and diluted net loss per share, compared to $22.1 million, or $0.43 basic and diluted net loss per share, for the prior year period.
2019 Guidance
AcelRx added the number of REMS-certified facilities as another metric in addition to formulary approvals. These combined metrics provide a more comprehensive measure of healthcare facilities, including hospitals, ambulatory surgery centers, and other medically supervised settings which are purchasing or are certified to purchase DSUVIA. Our expectation is there will be 125 REMS-certified facilities by the end of 2019, which is in line with the 125 formulary wins expected by the end of 2019. As we gain more experience with the launch, we plan to provide updates on both metrics measuring access to medically supervised settings.
Quarterly combined R&D and SG&A expense for the remaining quarters of 2019 is expected to remain in the range of $16 million to $18 million, which includes approximately $2 million of non-cash stock-based compensation per quarter. Quarterly debt service for the last two quarters of the year is expected to approximate $0.6 million.
Quarterly non-cash interest income for the rest of 2019 is expected to approximate $1.0 million mainly attributed to the accounting for the reduction in the expected liability related to the previously recorded sale of Zalviso royalties and milestones.
2019 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 the safe harbor statements below.
Webcast and Conference Call Information
As previously announced, AcelRx will host a live webcast Monday, August 5, 2019 at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of the company’s website at www.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 the company’s website at www.acelrx.com.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 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 in adult patients 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 (SDA) by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (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 Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.
For more information, please visit www.DSUVIA.com.