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Talphera(TLPH) - 2022 Q1 - Quarterly Report
2022-05-16 13:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdictio ...
Talphera(TLPH) - 2021 Q4 - Earnings Call Transcript
2022-03-11 04:55
AcelRx Pharmaceuticals, Inc. (ACRX) Q4 2021 Earnings Conference Call March 10, 2022 4:30 PM ET Company Participants Raffi Asadorian - Chief Financial Officer Vincent Angotti - Chief Executive Officer Pamela Palmer - Chief Medical Officer Lakhmir Chawla - Chief Medical Officer, Silver Creek Pharmaceuticals, Inc. Conference Call Participants Ed Arce - H.C. Wainwright & Co. Brandon Folkes - Cantor Fitzgerald & Co. Operator Good day and welcome to the AcelRx Fourth Quarter and Full Year 2021 Earnings Call. This ...
Talphera(TLPH) - 2021 Q4 - Annual Report
2022-03-10 22:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction of inc ...
Talphera(TLPH) - 2021 Q3 - Earnings Call Transcript
2021-11-15 15:26
AcelRx Pharmaceuticals, Inc. (ACRX) Q3 2021 Earnings Conference Call November 15, 2021 8:00 AM ET Company Participants Raffi Asadorian – Chief Financial Officer Vincent Angotti – Chief Executive Officer Pamela P. Palmer – Chief Medical Officer Conference Call Participants Thomas – H.C. Wainwright Ed Arce – H.C. Wainwright Operator Welcome to the AcelRx Third Quarter, 2021 earnings call. This call is being webcast live on the events page of the investors section of AcelRx 's website at www.acelrx.com. This c ...
Talphera(TLPH) - 2021 Q3 - Quarterly Report
2021-11-15 11:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdi ...
Talphera(TLPH) - 2021 Q2 - Earnings Call Transcript
2021-08-16 23:19
AcelRx Pharmaceuticals, Inc. (ACRX) Q2 2021 Results Conference Call August 16, 2021 4:30 PM ET Company Participants Vincent Angotti – Chief Executive Officer Raffi Asadorian – Chief Financial Officer Pamela P. Palmer – Chief Medical Officer Conference Call Participants Brandon Folkes – Cantor Fitzgerald Ed Arce – H.C. Wainwright & Co Michael J. Higgins – Ladenburg Thalmann Operator Welcome to the AcelRx Second Quarter 2021 Earnings Call. This call is being webcast live on the events page of the Investors se ...
Talphera(TLPH) - 2021 Q2 - Quarterly Report
2021-08-16 20:16
FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction ...
Talphera(TLPH) - 2021 Q1 - Earnings Call Transcript
2021-05-18 01:56
AcelRx Pharmaceuticals, Inc. (ACRX) Q1 2021 Earnings Conference Call May 17, 2021 4:30 PM ET Company Participants Raffi Asadorian - Chief Financial Officer Vince Angotti - Chief Executive Officer Pam Palmer - Chief Medical Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Michael Higgins - Ladenburg Thalmann Ed Arce - H.C. Wainwright Operator Welcome to the AcelRx First Quarter 2021 Earnings Call. This call is being webcast live on the events page of the Investors section of AcelRx's w ...
Talphera(TLPH) - 2021 Q1 - Quarterly Report
2021-05-17 20:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended March 31, 2021 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdictio ...
Talphera(TLPH) - 2020 Q4 - Earnings Call Transcript
2021-03-16 01:58
Financial Data and Key Metrics Changes - Q4 2020 revenues were $0.7 million, a 55% increase from $0.5 million in Q4 2019 [65] - Total 2020 product sales reached $2.5 million, a 38% increase from $1.8 million in 2019 [65] - Gross profit was negative for the quarter and year, but losses narrowed compared to 2019, with expectations for continued improvement as sales grow [67] Business Line Data and Key Metrics Changes - The company achieved significant progress in its four pillars, including a $3.6 million contract from the U.S. Army and a partnership with Zimmer Biomet for oral and dental surgery [14][18] - The orthopedic surgery market is identified as a key specialty for DSUVIA in 2021, with ongoing studies showing benefits such as faster discharge times and reduced opioid use [28][99] Market Data and Key Metrics Changes - The backlog of elective surgeries has grown significantly, with expectations for a ramp-up in surgeries in the second half of 2021 as COVID-19 restrictions ease [12][66] - The company anticipates having 615 hospitals and surgery centers approved for DSUVIA by the end of 2021 [70] Company Strategy and Development Direction - The company is focused on expanding its market presence through partnerships and addressing the backlog of elective surgeries [7][60] - Plans include exploring additional product licensing or acquisition opportunities to complement DSUVIA [61] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the return of elective surgeries and the potential for increased formulary approvals as restrictions are lifted [66][73] - The company is committed to improving access to healthcare institutions and expects stronger revenue growth in the second half of 2021 [66][73] Other Important Information - The automated packaging line is expected to significantly reduce production costs and increase capacity starting in Q3 2022 [58][68] - The company is addressing a recent FDA warning letter and is committed to proper promotion and education regarding DSUVIA [62][63] Q&A Session Summary Question: What are the current hospital protocols affecting DSUVIA? - Management noted that about one-fourth of formulary approvals have been for hospitals, with delays primarily due to COVID-19 [77][78] Question: What is the current status of formulary approvals? - As of the end of February, the company had 387 approvals and expects to reach 615 by year-end, with the second half of the year being crucial for this growth [85][86] Question: Are there any additional marketing efforts planned? - Management indicated that ongoing real-world data from investigator-initiated studies has been the strongest marketing tool, with no new promotional efforts planned [93] Question: What trends are being observed in outpatient versus inpatient procedures? - Management noted that while restrictions are still in place, there is a strong demand for outpatient procedures, particularly in orthopedics and plastics [99][100] Question: What is the expectation for the Milestone C approval from the DoD? - The company expects some procurement under the Milestone C this year, but logistics and administrative issues are still being worked through [112] Question: What proportion of formulary approvals are expected from targeted facilities? - The target includes 300 hospitals and 600 ambulatory surgery centers, with a focus on high-performing centers [115][116]