Urogen Pharma (NASDAQ:URGN) Posts Earnings Results, Misses Estimates By $0.14 EPS

Key Points

• UroGen reported a quarterly loss of $0.03 per share, missing analyst expectations of $0.11 EPS by $0.14; revenue of $89 million also came in slightly below the $89.92 million consensus.
• ZUSDURI revenue rose 35% sequentially to $68 million, and management expects further growth in Q4. JELMYTO revenue declined to $21 million, prompting the company to lower its full-year revenue outlook to about $90 million.
• The FDA accepted UGN-103’s application and set a June 14, 2027 decision date. Shares fell 16.7% on Wednesday, while management said it expects profitability and positive cash flow in Q4 2026.

Urogen Pharma (NASDAQ:URGN - Get Free Report) released its earnings results on Wednesday. The company reported ($0.03) EPS for the quarter, missing analysts' consensus estimates of $0.11 by ($0.14), FiscalAI reports. The firm had revenue of $89.00 million during the quarter, compared to the consensus estimate of $89.92 million.

Here are the key takeaways from Urogen Pharma's conference call:

• ZUSDURI revenue reached $68 million, up 35% sequentially. Prescribers increased to 662, repeat prescribers rose to 331, and management expects further quarter-over-quarter revenue growth in Q4 despite typical holiday seasonality.
• Management said the launch remains early, with broad adoption still developing: repeat prescribers were 50% of total writers, and the company estimated only a little over 10% of its core target urologists had prescribed ZUSDURI. It plans to expand patient-awareness efforts around mid-2027, while citing reimbursement confidence and practice workflows as adoption hurdles.
• JELMYTO revenue was $21 million, down from $22 million in Q2, and full-year revenue guidance was revised to approximately $90 million. The company cited a one-time $1.5 million gross-to-net adjustment and competition from clinical trials that is weighing on patient starts.
• The FDA accepted UGN-103’s NDA and set a June 14, 2027 PDUFA date; UroGen plans a potential launch in 2028, subject to approval and a permanent J-code. The company also expects to complete UGN-104 enrollment by year-end or early 2027, and has dosed the first patient in the UGN-501 Phase I trial.
• UroGen reported $90.5 million in cash and marketable securities, plus $117 million in accounts receivable, and management expects profitability and positive cash flow in Q4 2026. Operating expenses are now expected toward the upper end of the $260 million–$270 million guidance range.

Urogen Pharma Stock Down 16.7%

Shares of NASDAQ URGN traded down $5.75 during trading on Wednesday, reaching $28.65. 2,367,879 shares of the company traded hands, compared to its average volume of 848,294. Urogen Pharma has a 52-week low of $16.50 and a 52-week high of $50.81. The stock has a market capitalization of $1.40 billion, a PE ratio of -14.46 and a beta of 1.68. The firm has a 50 day simple moving average of $39.96 and a 200-day simple moving average of $31.42.

Insider Buying and Selling at Urogen Pharma

In other news, General Counsel Jason Smith sold 1,519 shares of Urogen Pharma stock in a transaction dated Tuesday, September 8th. The stock was sold at an average price of $42.54, for a total transaction of $64,618.26. Following the transaction, the general counsel directly owned 53,141 shares of the company's stock, valued at $2,260,618.14. The trade was a 2.78% decrease in their position. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available at this hyperlink. Also, insider Mark Schoenberg sold 60,677 shares of Urogen Pharma stock in a transaction on Thursday, August 20th. The shares were sold at an average price of $47.05, for a total transaction of $2,854,852.85. Following the transaction, the insider owned 59,086 shares in the company, valued at approximately $2,779,996.30. This trade represents a 50.66% decrease in their position. The SEC filing for this sale provides additional information. Over the last 90 days, insiders have sold 65,269 shares of company stock valued at $3,037,646. 4.80% of the stock is owned by company insiders.

Analyst Upgrades and Downgrades

A number of equities analysts have issued reports on URGN shares. Oppenheimer reiterated an "outperform" rating on shares of Urogen Pharma in a report on Wednesday, October 28th. TD Cowen boosted their target price on shares of Urogen Pharma from $50.00 to $60.00 and gave the company a "buy" rating in a report on Wednesday, August 5th. Jefferies Financial Group reaffirmed a "buy" rating and issued a $56.00 target price on shares of Urogen Pharma in a research report on Thursday, September 10th. Guggenheim increased their price target on shares of Urogen Pharma from $42.00 to $58.00 and gave the stock a "buy" rating in a research note on Thursday, August 6th. Finally, UBS Group reiterated a "buy" rating on shares of Urogen Pharma in a report on Thursday, July 9th. Eight investment analysts have rated the stock with a Buy rating, one has issued a Hold rating and one has given a Sell rating to the company's stock. According to data from MarketBeat, Urogen Pharma currently has a consensus rating of "Moderate Buy" and a consensus target price of $52.38.

About Urogen Pharma

UroGen Pharma Ltd. NASDAQ: URGN is a biopharmaceutical company focused on developing and commercializing treatments for cancers of the urinary tract. The company's therapies are designed to deliver medicines directly to the affected area, with the goal of improving drug exposure while limiting systemic side effects.

UroGen's primary commercial product is Jelmyto, a mitomycin-based treatment approved in the United States for adults with low-grade upper tract urothelial cancer. Jelmyto uses UroGen's proprietary RTGel technology, which forms a gel in the urinary tract and enables the sustained local release of mitomycin.

The company has also developed UGN-102, an investigational mitomycin-based reverse thermal gel intended for the treatment of low-grade, intermediate-risk non-muscle-invasive bladder cancer.

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