Viking Therapeutics(VKTX)
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Viking Therapeutics(VKTX) - 2025 Q3 - Earnings Call Transcript
2025-10-22 21:30
Financial Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $90 million, up from $22.8 million in Q3 2024, primarily due to increased clinical study expenses and salaries [6] - General and administrative expenses decreased to $8.6 million in Q3 2025 from $13.8 million in Q3 2024, mainly due to reduced legal and patent service costs [6] - The net loss for Q3 2025 was $90.8 million or $0.81 per share, compared to a net loss of $24.9 million or $0.22 per share in Q3 2024 [7][8] - For the first nine months of 2025, research and development expenses totaled $191.5 million, up from $70.7 million in the same period in 2024 [8] - The net loss for the first nine months of 2025 was $202 million or $1.80 per share, compared to a net loss of $74.5 million or $0.69 per share in the same period in 2024 [9] Business Line Data and Key Metrics Changes - The company announced positive top-line results from the phase two clinical trial of VK2735, achieving significant weight loss in patients with obesity [4][26] - VK2735 demonstrated statistically significant reductions in body weight, with up to 14.7% weight loss after 13 weeks in the Venture Oral Dosing Study [11][17] - The study also indicated that VK2735 was safe and well-tolerated, with most adverse events being mild or moderate [5][20] Market Data and Key Metrics Changes - The Vanquish Registration Program is currently enrolling approximately 4,500 patients for the obesity trial and 1,100 patients for the obesity and type 2 diabetes trial [13][14] - Enrollment for the Vanquish studies is proceeding well, with expectations to complete enrollment by the end of 2025 for Vanquish One and in Q1 2026 for Vanquish Two [14][25] Company Strategy and Development Direction - The company is advancing both subcutaneous and oral formulations of VK2735 for obesity treatment, aiming to provide options for patients [10][15] - A phase one study has been initiated to evaluate maintenance dosing regimens following initial weight loss achieved with VK2735 [23] - The company is also progressing with novel agonists targeting the amyloid receptor, with an IND filing expected in Q1 2026 [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the enrollment pace in the Vanquish studies, indicating enthusiasm for the program [29] - The company plans to submit an end-of-phase two meeting request to the FDA to discuss potential next steps for the oral formulation of VK2735 [26] - Management noted that the financial position is strong, with $715 million in cash available to support ongoing and future development programs [25] Other Important Information - The company is preparing for potential commercialization strategies, remaining open to partnerships while also being ready to proceed independently [82] - The results from the Venture Oral Dosing Study are expected to be published in a leading medical journal in early 2026 [12] Q&A Session Summary Question: Early signs of patient persistence and trial execution - Management noted that enrollment is ahead of schedule and there are no signs of persistence issues at this early stage [29] Question: Details on the maintenance study induction phase - The induction phase will involve titration up to doses of 17.5 mg, 20 mg, and 22.5 mg over 19 weeks [30] Question: Doses for monthly sub-Q, daily oral, and weekly oral being tested - Monthly doses will range from 15 mg to 22.5 mg, with daily doses at 17.5 mg and 27.5 mg, and weekly oral at 110 mg [34] Question: Next steps for validating a maintenance regimen - Management indicated that a longer study may be needed depending on the data from the maintenance study [38] Question: Impact of government shutdown on enrollment and timing - Management reported no significant impact from the government shutdown on enrollment or communication with the FDA [40] Question: Considerations for leveraging maintenance data with payers - Management emphasized the importance of persistence in therapy and ongoing discussions with payers regarding maintenance options [48] Question: Future plans for VK2809 in the MASH space - Management acknowledged increased interest in the MASH space and noted ongoing discussions regarding VK2809 [66]
Viking Therapeutics(VKTX) - 2025 Q3 - Earnings Call Transcript
2025-10-22 21:30
Financial Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $90 million, up from $22.8 million in Q3 2024, primarily due to increased clinical study expenses and salaries [8][10] - General and administrative expenses decreased to $8.6 million in Q3 2025 from $13.8 million in Q3 2024, mainly due to reduced legal and patent service costs [9] - The net loss for Q3 2025 was $90.8 million or $0.81 per share, compared to a net loss of $24.9 million or $0.22 per share in Q3 2024 [9][10] - For the first nine months of 2025, research and development expenses totaled $191.5 million, up from $70.7 million in the same period in 2024 [10] - The net loss for the nine months ended September 30, 2025, was $200 million or $1.80 per share, compared to a net loss of $74.5 million or $0.69 per share in the same period in 2024 [10][11] - Cash, cash equivalents, and short-term investments stood at $715 million as of September 30, 2025, compared to $93 million at the end of 2024 [11] Business Line Data and Key Metrics Changes - The company is advancing VK2735, a dual agonist for obesity, with both subcutaneous and oral formulations being developed [12][14] - The Phase II VENTURE oral dosing trial showed statistically significant weight loss reductions of up to 12.2% from baseline after 13 weeks [19][20] - The VANQUISH Phase III program is ongoing, targeting approximately 4,500 patients in one trial and 1,100 in another [15][16] Market Data and Key Metrics Changes - The obesity treatment market is seeing increased interest, with Viking's VK2735 positioned to compete effectively [27][28] - The company is exploring various dosing regimens for VK2735, including monthly subcutaneous and daily oral options [26][29] Company Strategy and Development Direction - Viking is focused on completing its Phase III trials for VK2735 while also pursuing additional programs targeting the amylin receptor [27][28] - The company plans to submit an end of Phase II meeting request to the FDA to discuss next steps for the oral formulation of VK2735 [24][29] - Viking is managing its balance sheet to ensure financial stability for ongoing and future development programs [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing enrollment in the VANQUISH studies and the positive results from the VENTURE oral dosing study [28][29] - The company is prepared to engage with potential partners for commercialization but is also ready to proceed independently if necessary [126] Other Important Information - Viking has seen a significant increase in interest in its NASH asset, reflecting a broader market trend [97] - The company is preparing for potential regulatory discussions regarding its oral formulation and its implications for future studies [88] Q&A Session Summary Question: Early signs of patient persistence in Phase III trials - Management noted that enrollment is ahead of schedule and there are no early signs of persistence issues [34][35] Question: Details on the maintenance study titration - The company is titrating patients up to target doses before transitioning to monthly dosing [36] Question: Monthly doses for maintenance study - Monthly doses will range from 15 mg to 22.5 mg, with daily oral doses at 17.5 mg and 27.5 mg [44] Question: Impact of government shutdown on enrollment - Management reported no significant impact from the government shutdown on enrollment or timelines [54] Question: Future clinical steps for maintenance regimen - Depending on data, the next step could involve a Phase 2b or Phase 3 study to validate the maintenance regimen [51] Question: Expectations for OpEx moving forward - R&D expenses are expected to remain elevated due to ongoing Phase III activities [96] Question: Considerations for the end of Phase II meeting - The focus will be on study design, duration, and leveraging existing safety data for the oral formulation [88] Question: Transitioning from subcutaneous to oral dosing - Management indicated that the oral study would follow a traditional titration approach [103] Question: Strategic interest in metabolic disease space - The company remains open to partnerships but is also prepared to proceed independently [126]
Viking Therapeutics(VKTX) - 2025 Q3 - Quarterly Results
2025-10-22 20:10
Financial Performance - Viking reported a net loss of $90.8 million, or $0.81 per share, for Q3 2025, compared to a net loss of $24.9 million, or $0.22 per share, in Q3 2024[23] - For the nine months ended September 30, 2025, Viking reported a net loss of $202.0 million, or $1.80 per share, compared to a net loss of $74.5 million, or $0.69 per share in the same period in 2024, indicating a significant increase in net loss[26] - Total operating expenses for the nine months ended September 30, 2025, were $228.6 million, compared to $104.7 million in the same period in 2024, showing a significant rise in overall expenses[34] Research and Development - Research and development expenses increased to $90.0 million for Q3 2025, up from $22.8 million in Q3 2024, primarily due to clinical studies and manufacturing costs[21] - Research and development expenses for the nine months ended September 30, 2025, were $191.5 million, up from $70.7 million in 2024, reflecting a substantial increase in investment in R&D[34] - VK2809 successfully achieved both primary and secondary endpoints in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis[30] - The company is developing VK0214 for the potential treatment of X-linked adrenoleukodystrophy (X-ALD), which showed safety and significant reductions in plasma levels of very long-chain fatty acids in a Phase 1b trial[30] Clinical Trials - VK2735 demonstrated statistically significant weight loss of up to 12.2% (26.6 lbs) in the Phase 2 VENTURE-Oral Dosing study after 13 weeks[10] - Enrollment in the Phase 3 VANQUISH-1 study is expected to be completed by the end of 2025, with VANQUISH-2 to follow in Q1 2026[9] - The Phase 3 VANQUISH program includes approximately 4,500 adults with obesity and 1,100 adults with obesity and type 2 diabetes[7] - Viking is currently evaluating VK2735 in a Phase 3 obesity program, which includes two Phase 3 clinical trials (VANQUISH-1 and VANQUISH-2)[30] - The company plans to file an IND for the dual amylin and calcitonin receptor agonist program in Q1 2026[20] - Viking's Phase 1 study of the oral VK2735 formulation showed up to 8.2% weight loss after 28 days of daily dosing[10] - The company expects to report results from the ongoing maintenance dosing study in mid-2026[19] Financial Position - The company has a strong cash position of $715 million at the end of Q3 2025, providing resources for ongoing clinical trials[4] - As of September 30, 2025, Viking held cash, cash equivalents, and short-term investments of $715 million, down from $903 million as of December 31, 2024[28] - Total current assets as of September 30, 2025, were $738.7 million, down from $907.2 million as of December 31, 2024[36] - The accumulated deficit as of September 30, 2025, was $689.9 million, compared to $487.9 million as of December 31, 2024, indicating an increase in accumulated losses[36] Administrative Expenses - General and administrative expenses decreased to $8.6 million in Q3 2025 from $13.8 million in Q3 2024, mainly due to reduced legal and patent service costs[22] - Interest income for the nine months ended September 30, 2025, was $26.7 million, compared to $30.1 million in 2024, indicating a decrease in interest income[34]
Viking Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Prnewswire· 2025-10-22 20:05
Core Insights - Viking Therapeutics reported strong progress in its clinical pipeline, particularly with VK2735, which has shown promising results in obesity treatment [2][3][6] - The company announced a net loss of $90.8 million for Q3 2025, significantly higher than the $24.9 million loss in Q3 2024, primarily due to increased research and development expenses [11][14] - Viking's cash position remains robust at $715 million, providing sufficient resources for ongoing clinical trials and development programs [15] Clinical Pipeline Updates - VK2735, a dual agonist targeting GLP-1 and GIP receptors, achieved significant weight loss results in the Phase 2 VENTURE-Oral Dosing study, with reductions of up to 12.2% from baseline [2][6] - The Phase 3 VANQUISH trials for VK2735 are on schedule, with enrollment expected to complete by the end of 2025 for VANQUISH-1 and in Q1 2026 for VANQUISH-2 [3][5] - Viking is also advancing an oral formulation of VK2735, which has shown encouraging safety and efficacy in early studies, and plans to file an IND for its amylin agonist program in Q1 2026 [6][9][12] Financial Performance - Research and development expenses for Q3 2025 were $90 million, up from $22.8 million in Q3 2024, reflecting increased clinical study costs and regulatory services [8][12] - General and administrative expenses decreased to $8.6 million in Q3 2025 from $13.8 million in Q3 2024, mainly due to reduced legal and patent service costs [10] - For the nine months ended September 30, 2025, total operating expenses reached $228.6 million, compared to $104.7 million for the same period in 2024 [21] Upcoming Events and Presentations - Viking plans to present at several upcoming scientific conferences, including ObesityWeek and the American Heart Association Scientific Sessions, to discuss its clinical programs and findings [9][18] - The company will host a conference call to discuss its Q3 2025 financial results, providing further insights into its operations and future plans [16]
Market Whales and Their Recent Bets on VKTX Options - Viking Therapeutics (NASDAQ:VKTX)
Benzinga· 2025-10-22 19:00
Core Insights - Investors are showing a bullish stance on Viking Therapeutics, with significant options activity indicating potential upcoming developments [1][2] - The overall sentiment among large traders is split, with 50% bullish and 25% bearish positions noted [2] - Major market movers are focusing on a price range between $25.0 and $60.0 for Viking Therapeutics over the last three months [3] Options Activity - A total of 12 options trades were detected, with 11 being calls amounting to $1,067,687 and only 1 put totaling $41,820 [2] - The mean open interest for options trades today is 1,909, with a total volume of 3,526 [4] - Significant trades include bullish call options with strike prices at $60.00 and $25.00, with total trade prices of $260.2K and $141.5K respectively [9][10] Company Overview - Viking Therapeutics specializes in biopharmaceutical development focused on metabolic and endocrine disorders, with a pipeline that includes VK2809, VK5211, and VK0214 [11] - The company is currently trading at $30.99, down by 6.03%, with a trading volume of 2,560,725 [16] - Analysts have proposed an average target price of $102.0 for Viking Therapeutics, indicating potential upside [13][14]
Viking Therapeutics Announces Initiation of VK2735 Maintenance Dosing Clinical Trial in Patients with Obesity
Prnewswire· 2025-10-21 11:05
Core Insights - Viking Therapeutics has initiated a Phase 1 exploratory maintenance dosing study for VK2735, a dual agonist targeting GLP-1 and GIP receptors, aimed at evaluating various dosing regimens to maintain weight loss achieved through initial treatment [1][2][3] Study Details - The study will involve approximately 180 adults with obesity (BMI ≥ 30 kg/m²) who are otherwise healthy, transitioning from initial weekly subcutaneous doses of VK2735 or placebo for 19 weeks to various maintenance dosing options [2] - Maintenance options include monthly subcutaneous doses, daily oral doses, weekly oral doses, or placebo, with objectives to assess safety, tolerability, and pharmacokinetics [2] - Exploratory endpoints will measure changes in body weight from baseline and from Week 19 to Week 31 [2] Company Overview - Viking Therapeutics focuses on developing novel therapies for metabolic and endocrine disorders, with VK2735 being a key compound in their pipeline [5][6] - The company is also conducting two Phase 3 studies (VANQUISH-1 and VANQUISH-2) to evaluate the efficacy and safety of subcutaneous VK2735 over 78 weeks [3][6] - Viking's research includes other compounds like VK2809 for lipid and metabolic disorders and VK0214 for X-linked adrenoleukodystrophy [6]
The Trump Market Rollercoaster: A Daily Dose of Volatility
Stock Market News· 2025-10-20 06:00
Market Reactions to Presidential Announcements - The U.S. stock market has shown extreme sensitivity to presidential announcements, particularly those from President Trump, leading to significant volatility in stock prices [2][4][12] - On October 10, 2025, the S&P 500 dropped by 2.71%, the Nasdaq 100 fell by 3.56%, and the Dow Jones Industrial Average decreased by 1.90% following the announcement of a 100% tariff on Chinese imports [3] - A previous social media post regarding a "China cooking oil threat" resulted in a loss of $450 billion in market value within minutes, highlighting the immediate impact of presidential rhetoric on market stability [4] Corporate Responses to Tariffs - Companies like IBM have managed to mitigate the impact of tariffs, with its CFO stating that tariffs have a "minimal impact" due to diversified supply chains, where imported goods account for less than 5% of overall spending [6] - The semiconductor sector, including Nvidia and AMD, faced significant declines due to the tariff announcements, with Nvidia dropping nearly 5% [3] Pharmaceutical Sector Impact - President Trump's announcement on October 17, 2025, to reduce the price of Ozempic from around $1,000 to $150 led to a decline in shares for Novo Nordisk, which fell between 5% and 6.4%, and Eli Lilly, which saw a drop of 4% to 5.3% [7][8] - Analysts from JPMorgan and BMO Capital Markets suggested that the market's negative reaction to the price cuts was overblown, indicating that many insured individuals already pay significantly lower prices for similar medications [9] Global Trade Dynamics - Colombia is facing potential tariffs and a cessation of U.S. aid due to drug trade issues, with current tariffs at 10% on most U.S. imports [10] - India has been warned of "massive tariffs" if it continues purchasing Russian oil, although immediate market reactions to these threats were not evident, suggesting a level of investor desensitization to such rhetoric [11] Overall Market Trends - As of October 20, 2025, the S&P 500 gained 0.23% to 6680 points, the Dow Jones increased by 0.52% to 46,256.04, and the Nasdaq rose by 0.65% to 24,916.79, indicating a recovery following earlier declines [12] - The market has developed a pattern of reacting sharply to announcements, followed by a recovery as details emerge, illustrating a cycle of "sell the tweet, buy the clarification" [12]
The Trump Market: A Daily Dose of “What Now?”
Stock Market News· 2025-10-18 18:00
Market Reactions to Trade Policies - In early October 2025, President Trump's threat of "massive" new tariffs on Chinese goods led to significant market declines, with the S&P 500 dropping 2.71%, the Dow Jones Industrial Average down 1.90%, and the Nasdaq 100 falling 3.49% [2] - A subsequent post on Truth Social by Trump on October 13 reassured investors, resulting in a market rebound where the Dow surged over 500 points, the S&P 500 gained 1.24%, and the Nasdaq climbed 1.54% [3] - On October 17, Trump's comments about tariffs being "not sustainable" and a meeting with Chinese President Xi Jinping prompted a modest rebound in U.S. stock indices, with the Dow advancing 0.2% and the Nasdaq recovering from earlier losses [4] Pharmaceutical Industry Developments - President Trump announced a deal with Merck KGaA on October 17 to reduce the prices of IVF drugs by 84%, which is expected to save families around $2,200 per IVF cycle, while also providing Merck with tariff reprieves and expedited drug reviews [5] - Conversely, Trump's announcement regarding the potential price drop of the weight-loss drug Ozempic to $150 from around $1,000 led to a sharp decline in shares for Novo Nordisk, which fell as much as 6%, and similar declines for Eli Lilly and other competitors [6][7] - Analysts expressed skepticism about Trump's price target for Ozempic, labeling it as "aggressive posturing" and noting that insured patients already pay significantly less [8] Impact of Social Media on Market Sentiment - Trump's posts on Truth Social have become a barometer of market sentiment, with the stock of Digital World Acquisition Corp. (DWAC) experiencing a 67.18% decline year-to-date, hitting a 52-week low of $7.57 [9] - Despite optimistic forecasts for DWAC, the reality has been a downward trajectory, with predictions of further declines [9] Overall Market Dynamics - The market's reaction to Trump's policies is characterized by rapid fluctuations, with significant drops and rebounds driven by tariff rhetoric and casual comments on drug prices [10] - Investors are in a state of constant alertness, adapting to the unpredictability of Trump's announcements and the resulting market impacts [10]
Viking Therapeutics (VKTX) Receives a Buy from Oppenheimer
Yahoo Finance· 2025-10-18 01:54
Viking Therapeutics, Inc. (NASDAQ:VKTX) is one of the best healthcare stocks with the highest upside. Viking Therapeutics, Inc. (NASDAQ:VKTX) received a Buy rating from Oppenheimer’s Jay Olson on October 7, who assigned a $100 price target to the stock’s shares. Viking Therapeutics (VKTX) Soars 9.7% on Looming Weight Loss Drug Trial Results H.C. Wainwright analyst Joseph Pantginis also reiterated a bullish stance on Viking Therapeutics, Inc. (NASDAQ:VKTX) on September 22, giving the stock a Buy rating wi ...
Viking Therapeutics, Inc. (VKTX) Stock Dips While Market Gains: Key Facts
ZACKS· 2025-10-17 22:45
Company Performance - Viking Therapeutics, Inc. (VKTX) shares decreased by 3.44% to $33.54, underperforming the S&P 500's daily gain of 0.53% [1] - Over the last month, the company's shares increased by 33.37%, significantly outperforming the Medical sector's gain of 2.87% and the S&P 500's gain of 0.71% [1] Earnings Projections - The upcoming earnings report for Viking Therapeutics is scheduled for October 22, 2025, with projected earnings per share (EPS) of -$0.7, indicating a 218.18% decrease from the same quarter last year [2] - For the annual period, Zacks Consensus Estimates predict an EPS of -$2.45 and revenue of $0 million, reflecting shifts of -142.57% and 0% respectively from the previous year [3] Analyst Estimates and Rankings - Recent adjustments to analyst estimates for Viking Therapeutics are crucial as they reflect near-term business trends, with positive changes indicating a favorable outlook on business health and profitability [3] - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), currently ranks Viking Therapeutics at 4 (Sell), with a consensus EPS projection having moved 1.06% higher in the past 30 days [5] Industry Context - The Medical - Biomedical and Genetics industry, which includes Viking Therapeutics, holds a Zacks Industry Rank of 83, placing it in the top 34% of over 250 industries [6] - The Zacks Industry Rank assesses the strength of specific industry groups, with research indicating that the top 50% rated industries outperform the bottom half by a factor of 2 to 1 [6]