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Eyenovia(EYEN) - 2022 Q3 - Quarterly Report
2022-11-13 16:00
Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 Par Value EYEN Nasdaq Capital Market 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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMIS ...
Eyenovia(EYEN) - 2022 Q3 - Earnings Call Transcript
2022-11-11 02:52
Eyenovia, Inc. (NASDAQ:EYEN) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Eric Ribner - Investor Relations Michael Rowe - Chief Executive Officer John Gandolfo - Chief Financial Officer Conference Call Participants Leonard Yaffe - Stoc Doc Partners Operator Good day and welcome to the Eyenovia’s Third Quarter 2022 Earnings Call. Today's conference is being recorded. At this time I would like to turn the conference over to Eric Ribner, LifeSci Advisors. Please go ahead. ...
Eyenovia(EYEN) - 2022 Q2 - Earnings Call Transcript
2022-08-11 02:51
Eyenovia, Inc. (NASDAQ:EYEN) Q2 2022 Earnings Conference Call August 10, 2022 4:30 PM ET Company Participants Eric Ribner - Investor Relations Sean Ianchulev - Chairman Michael Rowe - Chief Executive Officer John Gandolfo - Chief Financial Officer Conference Call Participants Matt Kaplan - Ladenburg Thalmann Leonard Yaffe - Stoc Doc Partners Operator Ladies and gentlemen, greetings and welcome to the Eyenovia Second Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conferenc ...
Eyenovia(EYEN) - 2022 Q2 - Quarterly Report
2022-08-10 16:00
Table of Contents | --- | --- | |----------------------------------------------------------------------------|-------------------------------------------------------| | | | | DELAWARE | 47-1178401 | | (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | | 295 Madison Avenue, Suite 2400 | | | NEW YORK, NY | 10017 | | (Address of Principal Executive Offices) | (Zip Code) | | Registrant's telephone number, including area code: | (917) 289-1117 | | Securities r ...
Eyenovia(EYEN) - 2022 Q1 - Earnings Call Transcript
2022-05-13 02:37
Eyenovia, Inc. (NASDAQ:EYEN) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET Company Participants Eric Ribner - Investor Relations Sean Ianchulev - President, Chief Executive Officer & Chief Medical Officer Michael Rowe - Chief Operating Officer John Gandolfo - Chief Financial Officer Conference Call Participants Tim Chiang - Northland Capital Operator Thank you for standing by, and welcome to the Eyenovia First Quarter 2022 Earnings Call. During the presentation, all participants will be in a list ...
Eyenovia(EYEN) - 2022 Q1 - Quarterly Report
2022-05-12 16:00
Table of Contents 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 REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER: 001-38365 EYENOVIA, INC. | --- | --- | --- | --- | --- | |------------------------------------------------------------------- ...
Eyenovia (EYEN) Investor Presentation - Slideshow
2022-05-01 13:33
eyenovia Making it Possible | April 2022 eyenovia.com Forward-Looking Statements Except for historical information, all the statements, expectations and assumptions contained in this presentation are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities ...
Eyenovia(EYEN) - 2021 Q3 - Earnings Call Transcript
2021-11-12 02:45
Eyenovia, Inc. (NASDAQ:EYEN) Q3 2021 Earnings Conference Call November 11, 2021 5:00 PM ET Company Participants Eric Ribner - Investor Relations Dr. Sean Ianchulev - Chief Executive officer and CMO Michael Rowe - Chief Operating Officer John Gandolfo - Chief Financial Officer Conference Call Participants Tim Chiang - Northland Capital Matt Kaplan - Ladenburg Thalmann Len Yaffe - Stoc*Doc Partners Operator Greetings. Welcome to Eyenovia’s Third Quarter 2021 Earnings Call. At this time, all participants are i ...
Eyenovia(EYEN) - 2021 Q1 - Earnings Call Presentation
2021-05-14 13:07
Making it Possible May 2021 Forward-Looking Statements 1 Except for historical information, all of the statements, expectations and assumptions contained in this presentation are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our product candi ...
Eyenovia(EYEN) - 2021 Q1 - Earnings Call Transcript
2021-05-13 02:35
Financial Data and Key Metrics Changes - For Q1 2021, the company reported a net loss of approximately $5.4 million or $0.21 per share, compared to a net loss of approximately $5.5 million or $0.31 per share for Q1 2020, indicating a slight improvement in loss per share [25] - Research and development expenses totaled approximately $4.2 million for Q1 2021, an increase of approximately 16.9% from approximately $3.6 million in the same period in 2020 [26] - General and administrative expenses were approximately $2.3 million for Q1 2021, up approximately 25.2% from approximately $1.8 million in Q1 2020 [26] - Total operating expenses for Q1 2021 were approximately $6.5 million, representing an increase of 19.7% compared to $5.5 million for the same period in 2020 [26] - As of March 31, 2021, the company's cash balance was approximately $24.9 million, excluding approximately $7.5 million in initial net proceeds from a $25 million credit facility with Silicon Valley Bank [27][28] Business Line Data and Key Metrics Changes - The company completed enrollment in its VISION-1 study of MicroLine, a proprietary pilocarpine formulation for improving near vision in presbyopia patients, with results expected shortly [9][18] - MydCombi, a fixed combination of two mydriatic medications, has a PDUFA date set for October 28, 2021, and is anticipated to transition the company to a commercial stage if approved [7][11] Market Data and Key Metrics Changes - The market opportunity for MydCombi is estimated at approximately $250 million annually in the U.S., with 80 million comprehensive diabetic eye exams and 4 million ophthalmic surgical dilations performed annually [14][15] - The presbyopia market, which affects approximately 113 million people in the U.S., has an estimated market potential of nearly $8 billion [20] Company Strategy and Development Direction - The company has entered into an exclusive agreement with EVERSANA to manage the distribution and order fulfillment of MydCombi, aiming for a streamlined launch process [8][17] - Eyenovia is focusing on out-licensing opportunities and pipeline expansion, leveraging Optejet technology for unmet needs in ophthalmic indications such as anti-infectives and glaucoma [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the upcoming PDUFA date for MydCombi and the potential for significant market opportunities in presbyopia and myopia treatments [30] - The company believes its current cash resources are sufficient to support operations through the third quarter of 2022, enabling the advancement of its clinical programs [28] Other Important Information - The company announced the addition of Dr. Julia Haller to its Board of Directors, which is expected to provide valuable insights as the company advances its programs [10] Q&A Session Summary Question: Comment on Allergan's Phase 3 study and its implications for Eyenovia - Management noted that while Allergan's study has been completed, they have not yet seen the data to make a comparative analysis, and they are optimistic about their own study's broader age range [34][35] Question: Plans for the VISION-2 study design - Management indicated that they plan to analyze VISION-1 results before finalizing the design for VISION-2, potentially making it more efficient based on the data [38][39] Question: Key endpoints to look for in VISION-1 results - Management highlighted that the primary endpoint is a three-line vision gain at near, but they also emphasized the importance of secondary endpoints and the side effect profile, particularly regarding brow ache [42][44]