Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. Reproxalap was statistically superior to vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), a U.S. Food and Drug Administration (FDA)-accepted symptom of dry eye disease.
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OhtuvayreTM (ensifentrine) now available; patient shipments started
Strong balance sheet supports commercialization and pipeline expansion
Conference call today at 9:00 a.m. EDT / 2:00 p.m. BST
“We are very pleased today to announce that Ohtuvayre (ensifentrine) is now available in the US for the maintenance treatment of chronic obstructive pulmonary disease ("COPD") in adults,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “Ohtuvayre is the first novel inhaled product available for the treatment of COPD in more than 20 years. Healthcare professionals ("HCPs") and patients are excited about Ohtuvayre’s potential to relieve COPD symptoms and we believe its bronchodilator and non-steroidal anti-inflammatory activity will redefine the treatment paradigm for COPD.
“Our field sales force began interacting with HCPs in late July and, to date, we have conducted over 2,000 HCP visits and more than 100 unique HCPs have prescribed Ohtuvayre through our exclusive network of specialty pharmacies. We are confident in the launch of Ohtuvayre and look forward to updating you on our progress.”
Conference Call and Webcast Information
Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Thursday, August 8, 2024, to discuss the second quarter 2024 financial results and the corporate update.
To participate, please dial one of the following numbers and ask to join the Verona Pharma call:
A live webcast will be available on the Events and Presentations link on the Investors page of the Company's website, www.veronapharma.com, and the audio replay will be available for 90 days. An electronic copy of the second quarter 2024 results press release will also be made available today on the Company’s website.
Guidance
For the third quarter and full year 2024, management is anticipating the following:
$ in millions | 3Q 2024 | 3Q 2023 | YoY Change |
Revenue1 | ~$193 - $197 | $180.0 | ~7% - 9% |
Adjusted Revenue1 | ~$193 - $197 | $190.0 | ~2% - 4% |
Adjusted EBITDA Margin3 | ~32% | ||
| |||
$ in millions | FY 2024 | FY 2023 | YoY Change |
Revenue1 | Low end of our previous | $750.3 | Low end of our previous |
Adjusted Revenue1 | Low end of our previous | $760.3 | Low end of our previous |
Adjusted EBITDA3 | >$255 | ||
“For the third quarter of 2024, we are guiding to revenue and Adjusted Revenue between $193 million and $197 million and Adjusted EBITDA Margin of about 32%,” said Karsten Voermann, Chief Financial Officer. “For the full year 2024, we expect revenue and Adjusted Revenue to be at the lower end of our previous guidance of $800 million to $810 million. The full year guidance includes approximately $5 million of anticipated impact from Rite Aid’s store closures. For the full year, we expect over $255 million of Adjusted EBITDA, up about 17% from 2023.”
“During the second quarter of 2024, our balance sheet remained robust and we recently successfully refinanced our credit facilities. Our capital allocation priorities are unchanged and we will continue to prioritize high return investments and maximizing value for shareholders,” concluded Voermann.
SUNRISE-PD to evaluate the effect of bezisterim (NE3107) on motor and non-motor symptoms in ~60 patients with Parkinson’s disease who are naïve to carbidopa/levodopa
Company engaged in trial start-up activities and plans to initiate patient screening Q4 2024
Conference Call
Aveanna will host a conference call on Thursday, August 8, 2024, at 10:00 a.m. Eastern Time to discuss our second quarter results. The conference call can be accessed live over the phone by dialing 1-877-407-0789, or for international callers, 1-201-689-8562. A telephonic replay of the conference call will be available until August 15, 2024, by dialing 1-844-512-2921, or for international callers, 1-412-317-6671. The passcode for the replay is 13746737. A live webcast of our conference call will also be available under the Investor Relations section of our website: https://ir.aveanna.com/. The online replay will also be available for one week following the call.
Q2 2024 Highlights and FY 2024 Outlook
Conference Call, Webcast Information, and Presentations
LifeStance will hold a conference call today, August 8, 2024 at 8:30 a.m. Eastern Time to discuss the second quarter 2024 results. Investors who wish to participate in the call should dial 1-800-715-9871, domestically, or 1-646-307-1963, internationally, approximately 10 minutes before the call begins and provide conference ID number 1488997 or ask to be joined into the LifeStance call. A real-time audio webcast can be accessed via the Events and Presentations section of the LifeStance Investor Relations website (https://investor.lifestance.com), where related materials will be posted prior to the conference call.
