UTHR Q2 Deep Dive: Tyvaso DPI Drives Growth Amid Pipeline and Competitive Uncertainty

Biotechnology company United Therapeutics (NASDAQ:UTHR) missed Wall Street’s revenue expectations in Q2 CY2025, but sales rose 11.7% year on year to $798.6 million. Its non-GAAP profit of $6.41 per share was 12.2% below analysts’ consensus estimates.

Is now the time to buy UTHR? Find out in our full research report (it’s free).

StockStory’s Take

United Therapeutics' second quarter saw sales increase year-on-year, but performance missed Wall Street’s expectations on both revenue and non-GAAP earnings per share, prompting a significant negative market reaction. Management attributed the double-digit revenue growth to continued strength in the Tyvaso franchise, particularly Tyvaso DPI, which achieved record patient shipments and robust new starts. CEO Martine Rothblatt highlighted operational efficiency and emphasized the company’s broad commercial portfolio, but acknowledged heightened competitive pressures, especially from new treprostinil products entering the market. President Michael Benkowitz noted, “We finished Q2 really strong in terms of shipments and orders in June. July, based on what we're seeing so far, looks really good.”

Looking ahead, United Therapeutics’ forward guidance centers on upcoming clinical milestones, most notably the TETON 2 readout in idiopathic pulmonary fibrosis, which management believes could reshape the company’s long-term growth profile. The company expects data from its ADVANCE OUTCOMES study in pulmonary arterial hypertension and the initiation of its organ transplantation studies to further expand its future opportunities. CFO James Edgemond stated, “Given the strength of our commercial business, our robust balance sheet, our confidence in our upcoming catalysts and our belief in our share price potential, we and the Board of Directors concluded that now was the right time to authorize the share repurchase.” Management also remains focused on maintaining strong operating efficiency while navigating regulatory and competitive developments.

Key Insights from Management’s Remarks

Management attributed the quarter’s growth to ongoing expansion of Tyvaso DPI, solid performance from legacy products, and preparation for key late-stage pipeline readouts. Competitive dynamics and investment in clinical programs were also highlighted as critical influences on recent results.

• Tyvaso DPI momentum: Tyvaso DPI (a dry powder inhaler for pulmonary hypertension) saw record shipments, elevated patient starts, and robust referral activity, underscoring ongoing uptake among physicians and patients despite new competing products entering the market.
• Portfolio breadth supports stability: Orenitram, Remodulin, and Unituxin all delivered double-digit revenue growth or near-record patient shipments, providing resilience and diversification beyond the Tyvaso franchise.
• Rising competition in PAH: Management addressed the launch of Liquidia’s Yutrepia, another dry powder treprostinil inhaler for pulmonary arterial hypertension (PAH), noting some physician experimentation but expressing confidence in Tyvaso DPI’s differentiated particle size, device usability, and patient support infrastructure.
• Late-stage pipeline progress: The TETON 2 Phase III study in idiopathic pulmonary fibrosis (IPF) completed enrollment, with results expected in September. Management emphasized the antifibrotic potential of treprostinil beyond its established vasodilatory effects, aiming for label expansion by 2027.
• Capital allocation for flexibility: The board authorized up to $1 billion in share repurchases through March of next year, reflecting ongoing operating cash flow and management’s intent to balance investment in pipeline innovation with shareholder returns.

Drivers of Future Performance

United Therapeutics’ outlook is driven by expectations for key clinical trial readouts, commercial execution of core products, and the evolving competitive landscape in pulmonary hypertension therapies.

• TETON 2 and pipeline catalysts: The imminent TETON 2 data in IPF could enable label expansion for Tyvaso, with management optimistic about treprostinil’s multi-receptor activity and antifibrotic potential. Success here would position the company for a commercial launch in 2027, supported by ongoing TETON 1 and ADVANCE OUTCOMES studies.
• Competition and market dynamics: Management acknowledged increased competition from Liquidia’s Yutrepia and other PAH therapies but emphasized Tyvaso DPI’s clinical data, device features, and established prescriber base as defenses against erosion. The company also highlighted plans for next-generation device launches and product improvements to maintain differentiation.
• Operational discipline and capital strategy: United Therapeutics plans to maintain strong operating efficiency while funding R&D and capital returns. The recent share repurchase authorization was presented as a means to deploy excess cash, with management noting ongoing flexibility to invest in the pipeline and respond to market shifts.

Catalysts in Upcoming Quarters

In the coming quarters, the StockStory team will closely watch (1) the September TETON 2 data readout for signs of efficacy in idiopathic pulmonary fibrosis and its implications for Tyvaso’s expansion, (2) market share trends for Tyvaso DPI as new PAH competitors enter the market, and (3) progress on next-generation product launches and broader pipeline milestones such as ralinepag and organ transplantation studies. Execution on these fronts will be central to United Therapeutics’ growth narrative.

United Therapeutics currently trades at $302.78, up from $297.16 just before the earnings. Is there an opportunity in the stock?Find out in our full research report (it’s free).

Our Favorite Stocks Right Now

Donald Trump’s April 2025 "Liberation Day" tariffs sent markets into a tailspin, but stocks have since rebounded strongly, proving that knee-jerk reactions often create the best buying opportunities.

The smart money is already positioning for the next leg up. Don’t miss out on the recovery - check out our Top 9 Market-Beating Stocks. This is a curated list of our High Quality stocks that have generated a market-beating return of 183% over the last five years (as of March 31st 2025).

Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-small-cap company Exlservice (+354% five-year return). Find your next big winner with StockStory today.

StockStory is growing and hiring equity analyst and marketing roles. Are you a 0 to 1 builder passionate about the markets and AI? See the open roles here.