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LENZ Therapeutics, Inc.(LENZ) - 2025 FY - Earnings Call Transcript
2025-12-04 16:30
Financial Data and Key Metrics Changes - The company launched its product in early October after receiving approval in late July, and within the first four weeks, it recorded 5,000 scripts written by 2,500 doctors, indicating strong initial interest and confidence in the product [27][29]. - Awareness of the product among doctors exceeded 90%, which is considered exceptional for a new product [12]. Business Line Data and Key Metrics Changes - The company has fully operational e-pharmacy and retail pharmacy channels, allowing consumers to order the product online or pick it up at local pharmacies [10]. - The company is seeing early signs of refill orders, although it is too early to provide specific metrics on refill rates [11][14]. Market Data and Key Metrics Changes - The product is skewing towards a slightly female demographic, with 60% of orders coming from women, primarily in the 45-55 age group [18][67]. - The company is targeting urban areas, which aligns with its initial market strategy [67]. Company Strategy and Development Direction - The company is focused on maximizing the launch of its product, with plans to turn on direct-to-consumer (DTC) marketing in Q1, which is expected to drive new patient starts [15][78]. - The company is also exploring international markets, with NDA submissions in South Korea and partnerships in Greater China and Canada [36][38]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's performance based on positive feedback from doctors and patients, noting that the product works effectively for nearly all patients [3][5]. - The company is aware of the competitive landscape, particularly regarding other products like Vuity, and believes its product has superior efficacy and a better market position [45][49]. Other Important Information - The company has established a strong marketing strategy, including the hiring of a celebrity spokesperson, Sarah Jessica Parker, to enhance brand awareness [19][78]. - The product is priced at $79 per month, which was determined through extensive market research to optimize revenue [69]. Q&A Session Summary Question: How is the launch going and what are the early metrics? - The company reported 5,000 scripts and 2,500 doctors writing prescriptions within the first four weeks, indicating strong interest [27][29]. Question: What is the strategy for direct-to-consumer marketing? - The company plans to launch DTC in Q1, focusing on building awareness and confidence among doctors before driving consumer demand [15][78]. Question: How does the company view its competitors? - The company sees itself as a category of one, with its product being the only pupil-selective miotic, and believes it has a significant advantage over competitors like Vuity [45][49].
LENZ Therapeutics (NasdaqGS:LENZ) FY Conference Transcript
2025-12-03 19:22
Summary of LENZ Therapeutics FY Conference Call Company Overview - **Company**: LENZ Therapeutics (NasdaqGS:LENZ) - **Product**: Presbyopia eye drop, a once-daily drop that restores near vision for individuals over 45 years old [2][3] Key Points Product Launch and Market Strategy - The product was approved at the end of July and launched in early October 2025 [2] - Focus for Q4 is to establish a solid base of doctors ready to prescribe the product before launching a direct-to-consumer (DTC) campaign in Q1 2026 [5][14] - Over 90% awareness among doctors within four weeks of launch, which is considered exceptional [7] - 2,500 doctors wrote prescriptions within the first four weeks, with over 5,000 paid and filled scripts [7][9] Distribution Channels - The company has established both e-pharmacy and conventional retail channels for product fulfillment [10][11] - Consumers can choose between e-pharmacy with fixed pricing and local pharmacies like CVS [11] - E-pharmacy volume is not trackable through traditional prescription data sources like IQVIA [12] Metrics and Growth Expectations - Initial focus on the number of doctors prescribing and the total scripts filled, with expectations for growth in new patient starts once DTC is activated [13][14] - Plans to provide updates on refill rates and prescription metrics in the second half of 2026 [18] Product Efficacy and Feedback - The product shows a duration of effect lasting 10-12 hours, with 70% of patients achieving at least 20/40 vision [21] - Anecdotal evidence suggests improvements in distance vision as well [23] - Side effects include mild stinging and redness, which typically resolve within a few days [24] Marketing Strategy - Sarah Jessica Parker is the spokesperson, targeting affluent, urban females aged 45-55 [27][28] - The marketing strategy will evolve to reach a broader presbyopic audience as awareness increases [28] Financial Position - The company has a healthy cash balance of approximately $325 million, sufficient to fund the launch and reach cash flow positivity by 2027 [31][32] - No plans to raise additional capital as the launch is well-funded [31] International Expansion - Significant opportunities exist in international markets, with licensing agreements in China, Korea, and Canada, and ongoing submissions in Europe [33][34] - The global presbyopic population is estimated at 1.8 billion, with 128 million in the U.S. alone [33] Investor Sentiment - Investors are optimistic about the product's potential, given its efficacy and the large target market [35] Additional Insights - The product's mechanism of action involves creating a small pinhole pupil, which enhances both near and distance vision [25][26] - The company is focused on ensuring that doctors set proper expectations for patients regarding the product's use and potential side effects [24]
LENZ Therapeutics (NasdaqGS:LENZ) FY Conference Transcript
2025-12-02 21:32
Summary of LENZ Therapeutics FY Conference Call Company Overview - **Company**: LENZ Therapeutics (NasdaqGS:LENZ) - **Product**: Viz, a presbyopia eye drop approved by the FDA in July 2025 and launched in October 2025 Key Points Product Launch and Market Performance - The launch of Viz has exceeded internal expectations with a 90% brand awareness achieved within two months of launch [3][4] - Over 7,000 offices received product samples, leading to over 2,500 doctors writing prescriptions and 5,000 filled prescriptions in the first four weeks [4][4] - The product is reported to work effectively for nearly all users, restoring near vision within 10-15 minutes and lasting throughout the workday [5][6] Efficacy and Safety - The product has shown a positive safety profile with minimal adverse effects reported, such as mild headaches and transient stinging upon application [9][10] - Anecdotal evidence suggests that Viz may also improve distance vision for some users, although this is not a labeled claim [6][14] - The product's comfort profile is favorable, with users adapting quickly to any initial dimness experienced [13][14] Direct-to-Consumer (DTC) Strategy - DTC advertising is set to begin in Q1 2026, targeting presbyopes, particularly those who have worn contact lenses or had LASIK surgery [16][19] - Sarah Jessica Parker has been announced as the brand spokesperson, supported by local influencers and digital advertising [17][23] - The DTC campaign aims to drive consumer awareness and increase prescriptions through eye care professionals [16][20] Pricing and Market Potential - Viz is priced at approximately $79 for a one-month supply, with a discount for three-month purchases [28][30] - The company anticipates a significant market opportunity, estimating a $3 billion market with 6% penetration translating to 8 million users [44] - The product is expected to appeal to a large demographic, including active aging individuals and those seeking convenience over traditional reading glasses [42][19] Competitive Landscape - Competitors Brimochol and Phentolamine are expected to enter the market in 2026, but LENZ believes Viz has a superior efficacy profile [49][50] - Viz maintains a significant advantage with a higher percentage of users achieving the desired pupil size for effective near vision improvement compared to competitors [50][51] Future Outlook - The company is focused on building a strong foundation with healthcare professionals before ramping up consumer advertising [16][45] - Initial feedback indicates a strong likelihood of daily use among patients, although conservative estimates suggest an average of three days per week for refill assumptions [43][44] - The company plans to monitor new patient starts and refill rates as key performance indicators in the coming quarters [44][48] Additional Insights - The product's adoption is primarily driven by enthusiastic doctors introducing it to patients during regular eye exams, with minimal consumer advertising currently in place [21][20] - The demographic data from e-pharmacy scripts indicates a slight female skew and a higher usage rate among individuals aged 45-65 [36][41]
LENZ Therapeutics Announces MFDS Submission of New Drug Application for LNZ100 (VIZZ™) in South Korea for the Treatment of Presbyopia
Globenewswire· 2025-12-01 13:30
Core Insights - Lotus Pharmaceutical has submitted a New Drug Application (NDA) for VIZZ in South Korea, marking the second regulatory submission for the drug outside the U.S. [1] - The NDA submission is backed by positive results from three Phase 3 studies in the U.S., demonstrating VIZZ's effectiveness in improving near vision [2] - Under the licensing agreement, LENZ Therapeutics stands to receive up to $125 million in milestone payments and royalties from future sales of VIZZ [3] Company Overview - LENZ Therapeutics is focused on the commercialization of VIZZ, the first FDA-approved aceclidine-based eye drop for presbyopia, which affects approximately 1.8 billion people globally [10] - Lotus Pharmaceutical, founded in 1966, is an international pharmaceutical company with a strong R&D and manufacturing platform, certified by major regulatory authorities [11] Product Information - VIZZ (aceclidine ophthalmic solution) 1.44% is designed to restore clear near vision for up to 10 hours and is preservative-free [6] - The drug is indicated for the treatment of age-related blurry near vision (presbyopia) in adults [7] Market Context - Presbyopia affects nearly all individuals over the age of 45, with significant implications for daily activities and quality of life [5] - The NDA submission in South Korea is part of a broader strategy to expand VIZZ's market presence in Southeast Asia, including countries like Thailand, Vietnam, and Malaysia [3]
LENZ Therapeutics, Inc.(LENZ) - 2025 Q3 - Quarterly Report
2025-11-05 21:10
Financial Performance - LENZ is focused on the commercialization of VIZZ™ (aceclidine ophthalmic solution) 1.44%, the first FDA-approved treatment for presbyopia, targeting a U.S. market opportunity exceeding $3 billion[143]. - The company reported an accumulated deficit of $191.2 million as of September 30, 2025, primarily due to research and development costs and selling, general, and administrative expenses[147]. - License revenue for the three months ended September 30, 2025, was $12.5 million, a significant increase from $0 in the same period of 2024[166][167]. - For the nine months ended September 30, 2025, license revenue was $17.5 million, compared to $0 in the same period of 2024[173][174]. - Other income, net for the nine months ended September 30, 2025, was $6.9 million, an increase from $6.3 million in the same period of 2024[178]. Cash and Investments - As of September 30, 2025, LENZ had $202.2 million in cash, cash equivalents, restricted cash, and marketable securities, which is expected to fund operations until positive operating cash flow is achieved[146]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $36.1 million, compared to $50.3 million in 2024[186][188]. - Cash provided by investing activities for the nine months ended September 30, 2025, was $14.1 million, driven by $162.6 million in proceeds from maturities of marketable securities[190]. - Cash used in investing activities for the nine months ended September 30, 2024, was $142.6 million, primarily due to $195.3 million of purchases of marketable securities[191]. - Cash provided by financing activities for the nine months ended September 30, 2025, was primarily driven by $26.1 million in net proceeds from common stock sold under the Sales Agreement[192]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $198.9 million, including $117.8 million in cash and cash equivalents acquired in the Merger[193]. Expenses - The company expects selling, general, and administrative expenses to continue increasing in 2025 as it builds a commercial team and supports the launch of VIZZ[158]. - Selling, general and administrative expenses rose by $21.1 million, or 325%, to $27.6 million for the three months ended September 30, 2025, compared to $6.5 million in 2024[168]. - Selling, general and administrative expenses increased by $32.1 million, or 165%, to $51.5 million for the nine months ended September 30, 2025, compared to $19.5 million in 2024[175]. - Research and development expenses decreased by $2.7 million, or 41%, to $3.8 million for the three months ended September 30, 2025, down from $6.5 million in 2024[170]. - Research and development expenses for the nine months ended September 30, 2025, decreased by $5.3 million, or 22%, to $18.7 million from $23.9 million in 2024[177]. Product Development and Licensing - LENZ achieved FDA approval for VIZZ on July 31, 2025, and launched the product in the U.S. in August 2025, with broader retail availability anticipated by mid-Q4 2025[145][156]. - License revenue increased due to upfront payments from the Lotus and Théa Licenses and two regulatory milestones under the CORXEL License, with no product sales revenue recorded yet[158]. - LENZ entered into a License and Collaboration Agreement with CORXEL, receiving $15.0 million in upfront payments and potential additional payments of up to $85.0 million in milestones[150]. - The Lotus License agreement provided a $5.0 million upfront payment and potential milestone payments of up to $120.0 million for commercialization in Southeast Asia[153]. - The Théa License agreement included a $2.5 million upfront payment and potential milestone payments of up to $67.5 million for commercialization in Canada[154]. Company Status and Compliance - The company is classified as an emerging growth company under the JOBS Act and may remain so until December 31, 2026[203]. - The company is also a "smaller reporting company" with a market value of stock held by non-affiliates less than $700 million as of June 30, 2025[205]. - The company does not have any off-balance sheet arrangements as defined by SEC rules[196]. - Recent accounting pronouncements are discussed in Note 2 of the condensed consolidated financial statements included in the Quarterly Report[206]. Operational Developments - The company entered into a lease for 9,795 square feet of office space in Solana Beach, California, with a term of thirty-nine months starting July 1, 2024, ending September 30, 2027[194]. - The company has contracts with various suppliers for the active pharmaceutical ingredient used in VIZZ, which can be modified or cancelled upon written notice[195].
LENZ Therapeutics, Inc.(LENZ) - 2025 Q3 - Earnings Call Transcript
2025-11-05 14:30
Financial Data and Key Metrics Changes - The third quarter of 2025 marked the first earnings call as a commercial company for LENZ Therapeutics, highlighted by the FDA approval of VIZ and its commercial launch in October [4][10] - The company ended Q3 2025 with approximately $324 million in cash, cash equivalents, and marketable securities, following a direct placement that raised over $123 million [10][25] - Total operating expenses for Q3 2025 increased to $31.4 million, a 44% increase over Q2, with SG&A expenses rising to $27.6 million compared to $6.5 million for the same period in 2024 [28][29] - The net loss per share was $0.59 in Q3 2025, compared to a net loss per share of $0.38 in Q3 2024 [29] Business Line Data and Key Metrics Changes - VIZ, the first pilocarpine-based eye drop for presbyopia, saw over 5,000 prescriptions filled in October, with more than 2,500 doctors prescribing it, and 40% of those prescribers writing multiple prescriptions [5][12] - The company distributed over 70,000 samples to approximately 7,000 eye care professional (ECP) offices, indicating strong engagement and interest [12][18] Market Data and Key Metrics Changes - Awareness among eye care professionals reached 90% by mid-October, driven by a robust multi-channel campaign [11][17] - The presbyopia market is significant, affecting approximately 128 million people in the U.S., which is nearly four times larger than the dry eye population [15] Company Strategy and Development Direction - The company aims to establish VIZ as a standard of care for presbyopia, focusing on building awareness, confidence, and willingness to prescribe among ECPs [11][20] - A direct-to-consumer (DTC) campaign is planned for Q1 2026, featuring Sarah Jessica Parker as the spokesperson to enhance brand visibility [10][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the launch of VIZ, noting positive feedback from doctors regarding its efficacy and minimal side effects [6][13] - The company anticipates that the cash on hand will support operations until achieving positive operating cash flow post-launch [25][30] Other Important Information - The company recorded total license revenue of $12.5 million in Q3 2025, including milestone payments from partnerships in China and Canada [26] - The company is focused on maintaining a lean G&A structure while increasing commercial spending to support the launch [28][29] Q&A Session Summary Question: How is the commercial team working with KOLs to set expectations for VIZ? - The company emphasizes setting expectations for patients regarding the efficacy and transient side effects of VIZ, with a focus on real-world experiences shared by doctors [34][36] Question: Can you provide week-over-week prescription data for October? - The company noted that it is too early to share specific trends but is encouraged by the initial prescription data [42][43] Question: What demographics are represented among the initial users of VIZ? - Initial users are primarily in the 45-65 age group, with a bias towards females, and are typically patients already in the practice [62] Question: How extensive will the DTC campaign be? - The DTC campaign will predominantly focus on digital platforms such as Instagram and Facebook, targeting where early adopters spend their time [62] Question: Can you break out the use of e-pharmacy versus traditional retail pharmacies? - Initially, the product was only available through e-pharmacy, with retail pharmacies coming online gradually; the company expects to track patient refills more effectively as retail availability increases [66][67]
LENZ Therapeutics, Inc. (LENZ) Reports Q3 Loss, Beats Revenue Estimates
Yahoo Finance· 2025-11-05 14:10
Core Insights - LENZ Therapeutics, Inc. reported a quarterly loss of $0.59 per share, which was better than the Zacks Consensus Estimate of a loss of $0.67, representing an earnings surprise of +11.94% [1] - The company generated revenues of $12.5 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 92.31%, compared to zero revenues a year ago [2] - LENZ Therapeutics shares have declined approximately 2.8% year-to-date, while the S&P 500 has increased by 15.1% [3] Earnings Outlook - The future performance of LENZ Therapeutics' stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4] - The current consensus EPS estimate for the upcoming quarter is -$0.92 on revenues of $3.46 million, and for the current fiscal year, it is -$2.62 on revenues of $14.27 million [7] Estimate Revisions - Prior to the earnings release, the estimate revisions trend for LENZ Therapeutics was favorable, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]
LENZ Therapeutics, Inc.(LENZ) - 2025 Q3 - Quarterly Results
2025-11-05 13:23
Product Approval and Market Impact - VIZZ (aceclidine ophthalmic solution) 1.44% received FDA approval for presbyopia treatment, impacting approximately 128 million adults in the U.S.[2] Prescription and Usage - Over 2,500 Eye Care Professionals (ECPs) have prescribed VIZZ, with 40% prescribing multiple times, resulting in over 5,000 prescriptions filled through October 2025[1][9] Financial Position - Pro forma cash, cash equivalents, and marketable securities were approximately $324.0 million as of September 30, 2025, anticipated to fund operations to post-launch positive cash flow[4] Expenses - Selling, General and Administrative (SG&A) expenses increased to $27.6 million for Q3 2025, compared to $6.5 million in Q3 2024, primarily due to increased personnel-related expenses[5] - Research and Development (R&D) expenses decreased to $3.8 million for Q3 2025, down from $6.5 million in Q3 2024, driven by reduced clinical trial-related expenses[6] Net Loss - Net loss for Q3 2025 was $16.7 million, or $0.59 per share, compared to a net loss of $10.2 million, or $0.38 per share, in Q3 2024[7][22] Milestones and Partnerships - The company achieved $10 million in milestone payments under its agreement with CORXEL Pharmaceuticals in China, including NDA submission for LNZ100[9] - A partnership with Sarah Jessica Parker as a direct-to-consumer campaign spokesperson is set to launch in Q1 2026[1][9] Revenue - Total revenue for Q3 2025 was $12.5 million, with license revenue contributing $12.5 million, compared to no revenue in Q3 2024[22] - Total operating expenses for the nine months ended September 30, 2025, were $70.2 million, compared to $43.4 million during the same period in 2024[22]
LENZ Therapeutics Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights
Globenewswire· 2025-11-05 13:00
Core Insights - LENZ Therapeutics, Inc. has received FDA approval for VIZZ (aceclidine ophthalmic solution) 1.44% for the treatment of presbyopia, marking it as the first and only aceclidine-based eye drop approved for this condition [1][5][17] - The commercial launch of VIZZ began in October 2025, with broad availability expected by mid-Q4 2025 [1][5] - The company has partnered with Sarah Jessica Parker for a direct-to-consumer campaign, set to launch in Q1 2026 [1][2][5] Commercial Highlights - Over 2,500 Eye Care Professionals (ECPs) have prescribed VIZZ, with 40% of them prescribing multiple times, leading to over 5,000 prescriptions filled by October 2025 [1][2][5] - Awareness of VIZZ among ECPs reached 90% in October 2025, supported by extensive marketing efforts including 17,000 unique ECPs detailed and over 5 million digital campaign impressions [5] - The company has provided nearly 70,000 product samples to approximately 7,000 ECP offices, contributing to increased confidence in prescribing VIZZ [5] Financial Overview - As of September 30, 2025, the company reported pro forma cash, cash equivalents, and marketable securities of approximately $324.0 million, which is expected to support operations until post-launch positive cash flow [1][6] - Selling, General and Administrative (SG&A) expenses increased significantly to $27.6 million for Q3 2025, compared to $6.5 million in Q3 2024, primarily due to increased personnel and marketing expenses [7] - Research and Development (R&D) expenses decreased to $3.8 million for Q3 2025, down from $6.5 million in Q3 2024, reflecting the completion of clinical trials [8] Net Loss - The net loss for the three months ended September 30, 2025, was $16.7 million, compared to a net loss of $10.2 million during the same period in 2024 [9][22] - For the nine months ended September 30, 2025, the net loss was $46.2 million, compared to $37.1 million in the same period in 2024 [9][22]
LENZ Therapeutics, Inc. (LENZ) May Find a Bottom Soon, Here's Why You Should Buy the Stock Now
ZACKS· 2025-10-30 14:56
Core Viewpoint - LENZ Therapeutics, Inc. (LENZ) has experienced a bearish price trend recently, losing 6.3% over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be increasing [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with selling pressure likely subsiding, which supports a bullish outlook for the stock [2][5]. - A hammer pattern forms when there is a small candle body with a long lower wick, signaling that bears may be losing control and bulls are starting to gain traction [4][5]. - This pattern can occur across various timeframes and is utilized by both short-term and long-term investors [5]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for LENZ, which is a bullish indicator suggesting potential price appreciation in the near term [7]. - The consensus EPS estimate for the current year has increased by 0.3% over the last 30 days, indicating strong agreement among analysts regarding the company's improved earnings potential [8]. - LENZ currently holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9][10].