Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the advancement and commercialization of Haduvio, a potential treatment for debilitating neurologically ...
Trevi Therapeutics is a clinical-stage biotechnology company focused on developing medicines for serious conditions in which abnormal sensory and neurological signaling contributes to persistent symptoms. The company’s principal asset is Haduvio, also described as oral nalbuphine extended release. Haduvio is an investigational, orally administered formulation designed to provide prolonged exposure ...Trevi Therapeutics is a clinical-stage biotechnology company focused on developing medicines for serious conditions in which abnormal sensory and neurological signaling contributes to persistent symptoms. The company’s principal asset is Haduvio, also described as oral nalbuphine extended release. Haduvio is an investigational, orally administered formulation designed to provide prolonged exposure to nalbuphine, an opioid receptor modulator. Trevi is studying the therapy in chronic pruritus, or severe and persistent itching, and in chronic cough experienced by patients with idiopathic pulmonary fibrosis. These conditions can substantially impair sleep, daily functioning, quality of life, and treatment adherence, while available therapies may be inadequate for some patients.
Trevi’s development strategy is centered on advancing Haduvio through late-stage clinical development and, subject to successful trials and regulatory review, commercialization. The supplied information indicates that Haduvio is undergoing Phase IIb/III clinical testing for relevant indications. Because the product remains investigational, Trevi does not yet have an established commercial product revenue base from Haduvio, and clinical outcomes, regulatory decisions, manufacturing readiness, financing, and market access will be important determinants of future value.
The company maintains a licensing agreement with Endo Pharmaceuticals Inc. that grants Trevi rights to develop and market products containing nalbuphine hydrochloride in various formulations. This arrangement provides access to the underlying active pharmaceutical ingredient and supports Trevi’s product-development strategy, although licensing terms can involve financial obligations, milestones, royalties, territory limitations, and other contractual conditions. Specific cost-of-goods, manufacturing, royalty, and milestone details are not provided in the supplied data. As a biotechnology company with a small workforce, Trevi is likely to rely on specialized contract research organizations, clinical-trial sites, contract manufacturers, and other external partners for portions of development and production. Its bill of materials would primarily involve active pharmaceutical ingredient, extended-release formulation components, packaging, quality-control testing, and clinical-supply logistics, but a detailed BOM is not publicly established in the supplied information.
Trevi is headquartered at 195 Church Street in New Haven, Connecticut, and reported 34 full-time employees. Jennifer L. Good serves as co-founder, President, and Chief Executive Officer, while Thomas Sciascia, M.D., is identified as co-founder and Chief Scientific Officer. The company went public on Nasdaq in 2019 under the symbol TRVI. The supplied financial snapshot shows a market capitalization of approximately $2.63 billion, no dividend, substantial liquidity relative to current liabilities, and negative operating results and cash flow, which are typical characteristics of a clinical-stage biotech still funding research and development. Reported trailing metrics include approximately $52.9 million of negative free cash flow and no meaningful product revenue. Trevi’s principal corporate objective is to generate clinical and regulatory evidence sufficient to support approval and eventual commercialization of Haduvio, while managing clinical, manufacturing, financing, intellectual-property, competitive, and regulatory risks.
YoYYoY means Year-over-Year. It compares the latest annual value with the previous annual value to show long-term trend strength.
QoQQoQ means Quarter-over-Quarter. It compares the latest quarter with the immediately previous quarter to show short-term momentum changes.
RevenueThe total money that came through the front door from selling things, before paying a single bill. Think of it as the grand total of every credit card swipe from customers. (YoY compares this year to last year's performance, while QoQ compares the current three months to the previous three).
$0
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Net IncomeThe absolute bottom line. If the company paid every single supplier, employee, banker, and tax collector, this is the actual money left in their pocket at the end of the day.
$-42.8M
+10.8%
-34.9%
Gross MarginThe basic markup. If they sell a $100 pair of sneakers, this percentage tells you how much of that price tag is profit right after paying for the rubber and shoelaces, but before paying for things like store rent or TV commercials.
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Operating MarginThe 'day job' efficiency score. Out of every dollar a customer spends, this shows how many cents the company keeps after making the product AND paying for all the everyday corporate overhead (like salaries, marketing, and keeping the lights on).
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Net MarginThe final take-home percentage. When you strip away every conceivable cost, tax, and interest payment, this is the exact number of cents the company truly gets to keep from every dollar in sales.
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Free Cash FlowThe holy grail of corporate cash. It's the spendable, physical money left over after the business pays for its daily operations AND buys the big, expensive upgrades (like new factories or servers) it needs to survive. This is the 'free' money they can use to pay dividends or buy back stock.
$-42.1M
-10.0%
-4.5%
FCF MarginThe ultimate cash conversion rate. It shows how good the company is at turning regular sales directly into cold, hard, spendable cash. A high percentage means the business is an absolute cash-printing machine.
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Debt / EquityThe financial risk gauge. It compares how much of the company's empire was built using borrowed money (loans) versus the owners' own money (shareholders). A high number means they are heavily leveraged and playing a riskier game; a low number means they are playing it safe.
0.4%
-60.3%
-52.5%
Current RatioThe 12-month survival check. It simply compares the cash they have right now (plus things they can quickly turn into cash) against the immediate bills they absolutely must pay this year. A score above 1 means they have enough in the wallet to cover the upcoming bills without panicking.
19.66x
+88.8%
+50.6%
Total AssetsThe absolute size of the company's empire. It bundles together absolutely everything of value they own—from the cash in the register and the inventory in the warehouse, to the software patents in the vault and the factories on the ground.
Operator: Good afternoon and welcome to the Trevi Therapeutics First Quarter 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. Various remarks that management makes during this conference call about the companys future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent annual report on Form 10-K, which the company filed with the SEC on March 17, 2026, as updated by our subsequent filings. In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so even if its views change. I would now like to turn the conference call over to Jennifer Good, Trevi's President and CEO. Please go ahead.
Jennifer Good: Good afternoon, and thank you for joining us for our first quarter 2026 earnings call and business update. Joining me today on this call are my colleagues, Dr. James Cassella, our Chief Development Officer; Farrell Simon, our Chief Commercial Officer; and David Hastings, our Chief Financial Officer. Dave and I will make some initial comments, but are going to keep them brief as we have a robust presentation this Thursday at our Investor and Analyst Day. After our comments on the quarter, the team is happy to answer any questions you may have. 2026 is an important year of execution for the company, and the team is focused on delivering. Following our positive FDA meeting in the first quarter to align on our IPF-related chronic cough program, the team has finalized the study protocols for our Phase III trials and has been busy identifying global sites for both pivotal studies. We expect to initiate the first of those 2 studies this quarter, followed by the second study in the second half of this year. After gaining alignment with the FDA in our end of Phase II meeting, we now intend to submit a meeting request and protocol to the FDA to discuss our non-IPF interstitial lung disease or non-IPF-ILD-reated chronic cough program. We intend to propose an adaptive Phase II/III study to confirm dose and powering assumptions in the Phase II study prior to rolling into 1 pivotal Phase III study for approval. If all goes as proposed to the FDA, we expect to initiate this trial in the second half of the year. This non-IPF-ILD population will mimic the patient profile of patients in our IPF trial as it will include patients who have established lung fibrosis and chronic cough. There are …