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Catalyst Rich 12 Months Ahead for U.S. Biopharma Co.

Source: Scott Henry


August 30, 2023 ( Newswire) Investors can expect to see new drug application filings, a PDUFA meeting outcome, clinical trial results and revenue stream additions, noted a ROTH Capital Partners report.

Fortress Biotech Inc. (FBIO:NASDAQ), "significantly undervalued," performed as expected in Q2/23 and has many stock catalysts ahead," reported ROTH Capital Partners analyst Scott Henry in an August 22 research note.

Return Remains Substantial

ROTH lowered its target price on the Florida-based biopharma company to US$2 per share from US$2.25 to "reflect depressed valuations for current public/private assets and a likely near-term reverse stock split." Fortress is currently trading at about US$0.45 per share in comparison.

This difference between these prices implies a significant potential return for investors of 344%.

Fortress is a Buy.

Future Successes Underestimated

As for Fortress being undervalued, Henry explained the company's current market cap of about US$60 million (US$60M) bakes in only two to three future successes despite the biopharma having 20 clinical programs in progress.

"This implies a 10-15% success rate," the analyst added, "which we believe may prove to be 50% or higher."

Key Q2/23 Figures

Henry reported that Fortress generated US$17.4M in revenue during Q2/23, more than ROTH's estimate of US$16.7M. Almost all of the US$17.4M came from Journey Medical, which has "turned momentum positive" in terms of operations and the pipeline. Journey is a company Fortress founded and now owns 50% of.

Fortress' operating expenses in Q2/23 were US$67.5M, below ROTH's forecast of US$69.4M.

The company posted a Q2/23 net earnings per share (EPS) loss of US$0.24, slightly higher than ROTH's predicted EPS loss of US$0.23.

Well-Performing Asset

Henry pointed out how well Journey Medical, which sells and markets drugs for dermatological conditions, is doing.

Coming off of a strong Q2/23, Arizona-based Journey is poised to turn adjusted operations cash flow neutral soon, noted Henry. In H2/23, it plans to file a new drug application (NDA) on DFD-29, its investigative rosacea treatment, supported by strong Phase 3 data. ROTH estimated that peak annual revenue from DFD-20 would exceed US$250M.

"This asset of Fortress appears pointed in the right direction," Henry commented.

What To Watch For

Fortress' pipeline is robust, noted Henry, and numerous stock catalysts are approaching for the biopharma.

Along with the submission of an NDA on DFD-29, events expected to happen this year include the completion of an NDA on CUTX-101, a treatment for Menkes disease. Fortress initiated the application but needs additional information on manufacturing to proceed.

Early next year, on Jan. 3, 2024, is the PDUFA date for cosibelimab for metastatic or locally advanced cutaneous squamous cell carcinoma.

Also, in 2024, potential milestones involving CAEL-101 for AL amyloidosis could occur. The asset is now in Phase 3. Another compound, dotinurad, could move to pivotal trials for gout.

Monetizations on the Horizon

Additional revenue streams could come online in 2024, wrote Henry, specifically from CUTX-101 and CAEL-101. Once CUTX-101 is approved, the sale of a priority voucher, estimated to happen in H2/24, would generate revenue for Fortress in the amount of US$50M-plus.

"Monetizations are key," Henry wrote. "We believe that investors will better appreciate the Fortress business model when monetizations become a more regular occurrence."

More Info: Newswire

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