What Viridian Therapeutics (VRDN) Said on Its Q3 Earnings Call

Key Points

• Lumvoa generated $24.7 million in its first quarter on the market, with more than 100 patients receiving an infusion by Sept. 30. Viridian said the launch exceeded expectations but cautioned it is too early to know whether the initial demand will continue.
• By quarter-end, payer policies covered 30% of eligible lives, mostly at parity with Tepezza; the company remains on track for broad coverage within six to nine months. Viridian ended the quarter with just over $955 million in cash and marketable securities, which it says can fund current plans through profitability.
• Viridian expects to submit a biologics license application for investigational subcutaneous TED treatment elegrobart in Q1 2027. It also expects VRDN-008 first-in-human results later this quarter and plans to begin a phase 1 trial of VRDN-292 in Graves’ disease.

Viridian Therapeutics NASDAQ: VRDN reported $24.7 million in net product revenue from Lumvoa in the thyroid eye disease treatment’s first quarter on the market, with more than 100 patients having received at least one infusion by Sept. 30.

President and CEO Steve Mahoney said the launch exceeded the company’s expectations, while executives cautioned that it remains too early to determine whether the initial pace will persist. Chief Commercial Officer Tony Casciano said most of the patients started treatment toward the end of the third quarter.

Chief Financial Officer Seth Harmon said Viridian ended the quarter with just over $955 million in cash, equivalents and marketable securities. He said the company has sufficient resources to fund its current business plans through profitability.

Early demand and coverage

Lumvoa is administered in five infusions over a 12-week course. Casciano said the company’s launch strategy is focused on converting prescriptions among approximately 2,000 core physicians who account for more than 80% of prescriptions for IGF-1R therapies in thyroid eye disease.

Asked whether the initial sales reflected a temporary surge of patients waiting for treatment, Casciano said Viridian did not believe that was the case. He noted that an existing therapy was already on the market and that thyroid eye disease can progress rapidly. He added that the company would need to observe demand over subsequent quarters.

Casciano also said there was little product stocking to speak of because infusion centers generally order Lumvoa once a patient is scheduled for treatment. The company included the patient-start figure, he said, to illustrate its view that revenue was driven by demand rather than inventory.

Viridian previously expected the period from an enrollment form to an infusion to typically take 60 to 90 days, based on its understanding of the experience with Tepezza. Casciano said the company was pleased with what it had seen so far but did not provide a conversion rate from enrollment forms to treatment.

By the end of September, 30% of covered lives had a payer policy in place for Lumvoa, Casciano said. He said those policies were at parity with Tepezza in almost all cases. The company remains on track for broad coverage within six to nine months of launch, he added.

Casciano noted that patients may also obtain access through medical exceptions or interim payer arrangements before a formal policy is established. Viridian said it had completed post-approval presentations with major payers representing more than 90% of U.S. covered lives; that figure reflects the reach of the presentations, not established coverage.

The Centers for Medicare & Medicaid Services assigned Lumvoa a permanent J-code effective Jan. 1, 2027. Casciano said Viridian has offered extended payment terms to help infusion centers manage cash flow while awaiting the code, but did not disclose the terms or how many patients were treated under the arrangement.

Fourth-quarter outlook and pipeline

Viridian did not issue fourth-quarter guidance. Casciano said the company anticipated some growth in the next quarter, with many of the patients who started late in the third quarter still on therapy, but said it was too early to have conviction about the rate of growth. He declined to comment on an analyst’s estimate of Lumvoa’s share of new patient starts.

The company is also preparing a biologics license application for elegrobart, an investigational subcutaneous anti-IGF-1R treatment for thyroid eye disease. Mahoney said Viridian remains on track to submit the application in the first quarter of 2027. The company envisions self-administration at home as infrequently as every eight weeks, subject to approval.

Viridian expects to disclose first-in-human results later in the fourth quarter for VRDN-008, an experimental half-life-extended FcRn inhibitor being developed for autoimmune diseases. Mahoney said the company would assess measures including IgG reduction, albumin sparing and dosing frequency.

The company also expects to begin a phase 1 trial of VRDN-292, an investigational anti-TSHR candidate, in patients with Graves’ disease later in the fourth quarter. Mahoney said the program is designed for infrequent subcutaneous delivery.

About Viridian Therapeutics (NASDAQ:VRDN)

Viridian Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on developing treatments for serious autoimmune diseases. The company's lead research area is thyroid eye disease (TED), a debilitating condition that can cause eye inflammation, swelling, pain and vision-related complications.

Viridian's pipeline is centered on antibodies designed to inhibit the insulin-like growth factor-1 receptor (IGF-1R), a target associated with TED. Its investigational therapies include veligrotug (VRDN-001), an intravenous treatment candidate, and VRDN-003, a subcutaneous formulation being developed to provide a more convenient administration option.

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