Aldeyra Therapeutics(ALDX)

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Aldeyra Therapeutics(ALDX) - 2019 Q4 - Earnings Call Transcript
2020-03-12 17:04
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) Q4 2019 Earnings Conference Call March 12, 2020 8:00 AM ET Company Participants Todd Brady - President & Chief Executive Officer Joshua Reed - Chief Financial Officer David McMullin - Chief Commercial Officer Conference Call Participants Louise Chen - Cantor Yigal Nochomovit - Citi Group Adam Walsh - Stifel Esther Hong - Janney I-Eh Jen - Laidlaw Matthew Cross - Jones Trading Operator Good morning and to welcome to the Aldeyra Therapeutics Full Year 2019 Financial Re ...
Aldeyra Therapeutics(ALDX) - 2019 Q3 - Earnings Call Transcript
2019-11-11 18:08
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) Q3 2019 Results Conference Call November 7, 2019 8:00 AM ET Company Participants Todd Brady - Chief Executive Officer Joshua Reed - Chief Financial Officer Conference Call Participants Yigal Nochomovitz - Citi Investment Research Sudan Loganathan - Cantor Fitzgerald & Company Esther Hong - Janney Montgomery Scott Adam Walsh - Stifel, Nicolaus & Company Matthew Cross - JonesTrading Institutional Services Operator Good morning and to welcome to the Aldeyra Therapeutics ...
Aldeyra Therapeutics(ALDX) - 2019 Q3 - Quarterly Report
2019-11-07 21:53
Financial Performance - The net loss for the nine months ended September 30, 2019, was $47,666,208, compared to a net loss of $28,260,061 for the same period in 2018, reflecting a 68.8% increase in losses[8] - The company reported a net loss per share of $0.69 for the three months ended September 30, 2019, compared to $0.52 for the same period in 2018, indicating a worsening loss per share[7] - Net loss for the nine months ended September 30, 2019, was $47,666,208, compared to a net loss of $28,260,061 for the same period in 2018, representing a 68.8% increase in losses[14] - The accumulated deficit increased from $138,535,168 as of December 31, 2018, to $186,201,376 as of September 30, 2019, indicating a rise of approximately 34.4%[5] Assets and Liabilities - Total current assets decreased from $94,769,286 on December 31, 2018, to $77,020,364 on September 30, 2019, representing a decline of approximately 18.8%[5] - Total liabilities increased significantly from $8,473,176 on December 31, 2018, to $26,561,705 on September 30, 2019, marking a rise of approximately 213.5%[5] - The total stockholders' equity decreased from $86,617,979 on December 31, 2018, to $50,879,294 on September 30, 2019, a decline of about 41.2%[5] - Cash and cash equivalents increased from $3,357,472 on December 31, 2018, to $25,604,203 on September 30, 2019, showing a substantial increase of approximately 663.5%[5] - Cash and cash equivalents as of September 30, 2019, were $51,604,203, up from $18,008,652 at the end of September 2018, indicating a significant increase in liquidity[14] Research and Development - Research and development expenses for the three months ended September 30, 2019, were $16,223,972, an increase of 106.8% compared to $7,880,822 for the same period in 2018[7] - The company incurred $6,500,602 in acquired in-process research and development expenses during the nine months ended September 30, 2019[14] - The company plans to conduct a Phase 3 clinical trial in dry eye disease (RENEW trial) and other trials, indicating ongoing investment in research and development[18] - The company reported stock-based compensation of $6,133,990 for the nine months ended September 30, 2019, compared to $3,126,920 for the same period in 2018, reflecting a 96.4% increase[14] Funding and Financing - The company needs to secure additional funding to support ongoing research and development activities and commercialization efforts[18] - The Company entered into a credit facility with Hercules Capital, Inc., providing for a term loan of up to $60.0 million, with $15.0 million outstanding as of September 30, 2019[38] - The term loan bears interest at a minimum annual rate of 9.10%, with interest-only payments until May 1, 2021, and total principal payments of $16.0 million due by October 1, 2023[39][40] - The Company sold 83,557 shares of common stock at a volume-weighted average price of $10.73, receiving $0.7 million after commissions during the nine months ended September 30, 2019[43] Stock and Compensation - The weighted average common shares outstanding for the three months ended September 30, 2019, were 27,111,600, up from 20,969,913 for the same period in 2018, an increase of approximately 29.9%[7] - The total stock-based compensation expense for the nine months ended September 30, 2019 was $4,529,956, compared to $3,126,919 for the same period in 2018, reflecting a year-over-year increase of approximately 45%[53] - The Company recognized unamortized stock-based compensation for all stock options of $9,712,699, which will be recognized over a weighted average period of 2.69 years[56] - As of September 30, 2019, the Company had options to purchase 4,539,279 shares of common stock at a weighted average exercise price of $6.64, with an aggregate intrinsic value of $1,881,826[55] Acquisitions - The Company acquired Helio Vision, Inc. on January 28, 2019, issuing a total of 1,150,990 shares of common stock, with 568,627 shares going to Helio's founders[25] - The acquisition resulted in an income tax benefit of $1.3 million and an increase in in-process research and development (IPR&D) expense of $6.5 million for the nine months ended September 30, 2019[27] - The Company assessed the Helio acquisition as an asset acquisition under ASC 805, indicating that the acquired assets did not constitute a business and required significant investment for development[27] Legal and Compliance - The Company is not aware of any pending legal proceedings that would materially impact its financial position or results of operations[64] - The Company has incurred losses since inception, resulting in a 100% valuation allowance against net deferred tax assets[45] - The Company has undergone three ownership changes through the year ended December 31, 2018, which may limit the utilization of its net operating losses[46]
Aldeyra Therapeutics(ALDX) - 2019 Q2 - Quarterly Report
2019-08-09 12:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 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: 001-36332 ALDEYRA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 20-1968197 (State or other jur ...
Aldeyra Therapeutics(ALDX) - 2019 Q2 - Earnings Call Transcript
2019-08-09 03:15
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) Q2 2019 Earnings Conference Call August 8, 2019 8:00 AM ET Company Participants Joshua Reed - CFO Todd Brady - CEO, President & Director Conference Call Participants Victor Rusu - Citigroup Esther Hong - Janney Montgomery Scott I-Eh Jen - Laidlaw & Company Matthew Cross - JonesTrading Institutional Services Operator Good morning. My name is Carol, and I will be your operator today. At this time, I would like to welcome everyone to the Aldeyra Therapeutics reports sec ...
Aldeyra Therapeutics(ALDX) - 2019 Q1 - Quarterly Report
2019-05-10 20:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 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: 001-36332 ALDEYRA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 20-1968197 (State or other ju ...
Aldeyra Therapeutics(ALDX) - 2019 Q1 - Earnings Call Transcript
2019-05-09 17:36
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) Q1 2019 Earnings Conference Call May 9, 2019 8:00 AM ET Company Participants Todd Brady - Chief Executive Officer Joshua Reed - Chief Financial Officer Conference Call Participants Samantha Semenkow - Citigroup Neil Carnahan - Stifel Financial Corp Esther Hong - Janney Montgomery Scott Matthew Cross - JonesTrading Operator Good morning and welcome to the Aldeyra Therapeutics First Quarter 2019 Financial Results and Corporate Update Conference Call. All participants w ...
Aldeyra Therapeutics(ALDX) - 2018 Q4 - Annual Report
2019-03-08 21:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For transition period from to Commission File Number 001-36332 ALDEYRA THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) Delaware 20-1968197 (State or other jurisdiction ...
Aldeyra Therapeutics(ALDX) - 2018 Q4 - Earnings Call Transcript
2019-03-08 17:22
Financial Data and Key Metrics Changes - For the year ended December 31, 2018, the company reported a net loss of approximately $38.9 million, compared to a net loss of approximately $22.3 million for the year ended December 31, 2017, indicating a significant increase in losses [11] - Basic and diluted net loss per share was $1.79 for the year ended December 31, 2018, compared to $1.40 per share for the same period last year [11] - Total operating expenses were approximately $39.7 million in 2018, compared to $22.5 million in the prior year [13] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses were $29.8 million for the year ended December 31, 2018, compared to $16.3 million for the same period in 2017, reflecting an increase of $13.5 million primarily due to increased clinical trial costs [11] - General and administrative expenses were $9.9 million for the year ended December 31, 2018, compared to $6.2 million for the year ended December 31, 2017, with the increase attributed to legal, patent-related, and consulting costs [12] Market Data and Key Metrics Changes - The company has five Phase 3 programs in progress or expected to be initiated in 2019, focusing on ocular diseases and select systemic conditions [6][7] - The market for dry eye disease is highlighted as one of the largest in ophthalmology, with current treatments deemed inadequate by patients and physicians [7] Company Strategy and Development Direction - The company aims to transition to a commercial stage company with a focus on developing next-generation medicines for immune-mediated diseases [6] - The acquisition of Helio Vision adds another Phase 3 ready product candidate, ADX-2191, targeting proliferative vitreoretinopathy, a rare retinal disease [8] - The company is exploring the potential for expanding its pipeline into systemic diseases, leveraging RASP inhibition as a new anti-inflammatory mechanism [37][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming milestones for 2019, including results from the ALLEVIATE Phase 3 clinical trial and the initiation of the RENEW Phase 3 clinical trial for dry eye disease [14] - The management emphasized the importance of frequent interactions with regulatory agencies to ensure alignment on clinical trial designs, particularly for reproxalap, a new chemical entity [25] Other Important Information - Cash, cash equivalents, and marketable securities were reported at $93.6 million as of December 31, 2018, which is expected to fund operating expenses through 2020 [13] Q&A Session Summary Question: Strategy regarding concentrations of reproxalap in AC and DED trials - Management explained the rationale for testing different concentrations in the trials to maintain flexibility in product profiles and to gather more information on safe and effective dosing [17][18] Question: Update on the ALLEVIATE trial and FDA discussions - Management confirmed ongoing discussions with the FDA regarding the ALLEVIATE trial and the potential for a second Phase 3 trial based on the results [25] Question: Insights on PVR and surgical quality - Management acknowledged the importance of surgical quality and variability among surgeons in the context of PVR and emphasized the need for a standardized surgical protocol [30] Question: Expansion plans in the dermatology space - Management indicated that there are no current limitations on the potential applications of reproxalap in dermatology beyond Sjögren-Larsson Syndrome, considering its anti-inflammatory properties [34] Question: Details on systemic pipeline products - Management highlighted the systemic program's potential and the decision to initiate clinical testing for systemic applications of RASP inhibition in 2019 [37][38]