Zevra Therapeutics(ZVRA)
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Zevra Therapeutics(ZVRA) - 2023 Q4 - Annual Results
2024-03-28 20:35
Exhibit 99.1 Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates Launch of OLPRUVA® underway Topline results from KP1077 phase 2 study demonstrate clinically meaningful benefits for key IH symptoms Q4 2023 net revenue of $13.2M, and FY 2023 net revenue of $27.5M Conference call scheduled for today, March 28, 2024, at 4:30 p.m. ET Celebration, FL – March 28, 2024 – Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics c ...
Zevra Therapeutics(ZVRA) - 2023 Q3 - Earnings Call Transcript
2023-11-11 05:36
Zevra Therapeutics, Inc. (NASDAQ:ZVRA) Q3 2023 Earnings Conference Call November 7, 2023 8:00 AM ET Company Participants Nichol Ochsner - Vice President of Investor Relations Neil McFarlane - President and Chief Executive Officer Christal Mickle - Co-Founder and Chief Product Development Officer LaDuane Clifton - Chief Financial Officer, Secretary and Treasurer Joshua Schafer - Chief Commercial Officer and Executive Vice President, Business Development Conference Call Participants Louise Chen - Cantor Fitzg ...
Zevra Therapeutics(ZVRA) - 2023 Q3 - Earnings Call Presentation
2023-11-10 13:01
Acquisition and Pipeline - Zevra's acquisition of Acer Therapeutics aims to accelerate growth into a commercial organization and expand the development pipeline[10] - The acquisition includes OLPRUVA, an FDA-approved product for urea cycle disorders (UCDs), and EDSIVO for vascular Ehlers-Danlos syndrome (vEDS)[8, 10] - Arimoclomol NDA resubmission for Niemann-Pick disease Type C (NPC) is expected in Q4 2023[8, 10] - Topline data for KP1077 in idiopathic hypersomnia (IH) is expected in H1 2024[8, 10] Financial Performance and Outlook - Zevra reported net revenue of $2.9 million for Q3 2023[35] - The company expects to earn the next AZSTARYS net sales milestone of $10 million this year[35] - As of September 30, 2023, Zevra had $83.4 million in cash, cash equivalents, and investments[35] Rare Disease Focus - Zevra is focused on delivering therapies addressing significant unmet needs in rare diseases[8] - Approximately 1,800 patients are diagnosed with Niemann-Pick disease Type C (NPC) in the U S and E U [20] - There are approximately 1,100 diagnosed Urea Cycle Disorder (UCD) patients, with over 800 being treated[11, 12] - An estimated 37,000 diagnosed idiopathic hypersomnia (IH) patients are actively seeking treatment in the US[28]
Zevra Therapeutics(ZVRA) - 2023 Q3 - Quarterly Report
2023-11-07 22:23
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 September 30, 2023 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: 001-36913 Zevra Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894398 (State or Other J ...
Zevra Therapeutics(ZVRA) - 2023 Q2 - Earnings Call Transcript
2023-08-17 18:57
Financial Data and Key Metrics Changes - For Q2 2023, net revenue was $8.5 million, driven by $5.8 million from AZSTARYS and $2.8 million from the French Early Access Program for arimoclomol [28] - The company reported a net loss of $5.1 million or $0.15 per share, primarily due to R&D expenses of $7.4 million and G&A expenses of $7 million [28][29] - As of June 30, 2023, cash, cash equivalents, and investments totaled $87.4 million, supporting operations into 2026 [12][30] Business Line Data and Key Metrics Changes - Year-to-date net sales of AZSTARYS surpassed $25 million, triggering a $5 million milestone payment [12][25] - The company earned royalties of $800,000 from AZSTARYS in Q2 2023, with expectations for continued growth in royalties over the coming years [26][27] Market Data and Key Metrics Changes - The AZSTARYS program is showing increasing weekly prescription counts, indicating growing demand in the ADHD treatment landscape [26] - The company is actively working on disease awareness initiatives for arimoclomol to enhance market access [18][19] Company Strategy and Development Direction - The company aims to resubmit the NDA for arimoclomol by the end of 2023, focusing on addressing FDA feedback from previous submissions [9][15] - Zevra is committed to developing therapies for rare diseases and enhancing in-house commercial capabilities [7][14] - The company is exploring opportunities to acquire new pipeline assets that complement its portfolio [60] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the collaborative nature of recent FDA meetings and the potential for a successful NDA resubmission [14][42] - The company is focused on three top priorities: resubmitting the arimoclomol NDA, completing the Phase II trial for KP1077, and expanding the KP1077 program into narcolepsy [59] Other Important Information - The company welcomed Tom Anderson to its Board of Directors, enhancing its expertise in commercial and rare disease sectors [13] - The total shares of common stock outstanding as of June 30 were 33,928,005, with fully diluted shares at 49,315,197 [30] Q&A Session Summary Question: Potential second net sales milestone for AZSTARYS - The second milestone is expected to be larger than the $5 million milestone earned in Q2, but specific details could not be disclosed [34] Question: Expectations for interim Phase II IH readout - The interim data will inform the Phase III trial design, focusing on dosing strategies [35] Question: Clarification on arimoclomol data handling with the FDA - The company is proceeding with the FDA's preferred primary analysis, which aligns with their original strategy [40] Question: Changes in FDA meeting tone and ADCOM request - The recent FDA meeting was collaborative, and while options for dispute resolution remain, the company is hopeful for a positive outcome [42][44] Question: Focus of the last FDA interaction - The majority of the last interaction focused on confirmatory evidence that had not been previously reviewed by the FDA [48] Question: Clarification on AZSTARYS revenue figures - The revenue figures were clarified, indicating that the $800,000 in royalties was not flat and included costs associated with the milestone [50][52]
Zevra Therapeutics(ZVRA) - 2023 Q2 - Quarterly Report
2023-08-14 20:34
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, 2023 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 No. 001-36913 Zevra Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894398 (State or Other Jurisdicti ...
Zevra Therapeutics (ZVRA) Investor Presentation - Slideshow
2023-05-18 17:57
Corporate Presentation 1 May 2023 Trademarks herein are held by their respective owners. Cautionary Note Regarding Presentation Information This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation and can be identified by the use of words such as "may," "will," "expect," "project," "estimate," "ant ...
Zevra Therapeutics(ZVRA) - 2023 Q1 - Quarterly Report
2023-05-15 21:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From to Commission File No. 001-36913 Zevra Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894398 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURI ...
Zevra Therapeutics(ZVRA) - 2022 Q4 - Earnings Call Transcript
2023-03-10 20:24
Financial Data and Key Metrics Changes - For the full year 2022, net revenue was $10.5 million, with Q4 net revenue at $2.3 million, primarily driven by reimbursements from the French EAP program [20][34] - The company reported a Q4 net loss of $9 million or $0.26 per share, and a full year net loss of $41.5 million or $1.20 per share, which includes a one-time noncash charge of $17.7 million related to in-process R&D assets [35][36] - Cash, cash equivalents, and investments as of December 31, 2022, were $102.9 million, expected to extend the cash runway into 2026 [20][36] Business Line Data and Key Metrics Changes - The arimoclomol program for Niemann-Pick Disease Type C is on track for NDA resubmission as early as Q3 2023, with positive interim data from a Phase II/III safety study presented at the 2023 WORLDSymposium [21][24] - The KP1077 program for rare sleep disorders is currently enrolling patients in a Phase II clinical study, with interim data expected by Q3 2023 and top-line data by the end of 2023 [27][29] Market Data and Key Metrics Changes - The prescription trend for AZSTARYS has improved since July 2022, with expectations to achieve sales milestones in 2023 [30][31] - Net revenue from the French EAP program is expected to continue at approximately $2 million per quarter throughout the year [37] Company Strategy and Development Direction - The company has shifted its focus exclusively to rare diseases, leveraging its strengths in drug development and regulatory approval to create value for shareholders [7][10] - The acquisition of arimoclomol is a strategic move to build commercial capabilities and retain market value for shareholders [10][15] - The company aims to commercialize its products in the U.S. and explore opportunities in other geographies, including the EU, Japan, and China [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial foundation and diverse portfolio, anticipating multiple value-creating milestones in 2023 [18][41] - The ongoing discussions with regulatory agencies are seen as productive, with preparations for NDA resubmission for arimoclomol [39][40] - The company is committed to creating value for shareholders while addressing the needs of patients with rare diseases [41][47] Other Important Information - The company has undergone a rebranding to Zevra Therapeutics to better reflect its commitment to rare disease patients [15][22] - The leadership team has been strengthened with new appointments, enhancing the company's capabilities in R&D and commercialization [21][23] Q&A Session Summary Question: Has there been any specific interactions with the FDA since your last update? - Management indicated that there have not been formal interactions with the FDA regarding the resubmission of the arimoclomol NDA [50] Question: What sales threshold triggers the AZSTARYS milestones? - The company expects to achieve one or two sales milestones likely toward the second half of 2023, but specific thresholds could not be disclosed [51][52] Question: Will the Phase II trial data for idiopathic hypersomnia influence the narcolepsy trial? - Management stated that they will evaluate the Phase II data before deciding on a parallel program for narcolepsy [53] Question: What is the current IP landscape of development assets? - The company has patents for arimoclomol that extend into the 2040s, with a focus on extending exclusivity beyond the orphan period [65][67] Question: What are the necessary hurdles for KP1077 approvability? - Management emphasized that while primary endpoints are crucial for approvability, additional exploratory endpoints will enhance the product's market competitiveness [72]
Zevra Therapeutics(ZVRA) - 2022 Q4 - Annual Report
2023-03-07 22:26
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to _____ Commission File No. 001-36913 Zevra Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894398 (State or Other Jurisdiction of I ...