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On Monday, H.C. Wainwright reaffirmed its Buy rating and price target of $221.00 for Krystal Biotech (NASDAQ:KRYS), a $5.16 billion market cap biotech company with impressive financial metrics according to InvestingPro data, following the recent positive development in the company’s European regulatory process. The company maintains strong financial health with a "GREAT" overall score and an exceptional gross profit margin of 93%. Krystal Biotech announced that on February 28, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a favorable opinion for the approval of VYJUVEK by the European Commission (EC). The final EC decision is anticipated in the second quarter of 2025.
If the EC approves VYJUVEK, it will be authorized for use across the European Union member states, as well as in Iceland, Norway, and Liechtenstein. This approval would represent the first international launch of VYJUVEK, following its U.S. approval and successful market introduction in 2023. The company has expressed satisfaction with the CHMP’s support for a broad label, which includes the treatment of patients from birth and offers administration options in both healthcare facilities and at home.
Krystal’s European team has already started preparations for the initial launch outside of the U.S., targeting Germany for a mid-2025 release. Following the German launch, several other European introductions are planned, with France expected in the second half of 2025. The company’s progress in Europe is particularly significant given the identified opportunity for treating dystrophic epidermolysis bullosa (DEB), as Germany and France alone have over 1000 identified DEB patients. With a strong current ratio of 7.28, InvestingPro analysis shows the company is well-positioned financially to support this expansion, with liquid assets significantly exceeding short-term obligations.
The analyst from H.C. Wainwright has expressed optimism about the continued growth trajectory for VYJUVEK and is looking forward to further regulatory updates. The reiteration of the Buy rating and the $221 price target underscores the firm’s positive outlook on Krystal Biotech’s stock, which currently trades near its InvestingPro Fair Value. The company’s remarkable revenue growth of 473% in the last twelve months and strong analyst consensus further support this positive outlook. For deeper insights into KRYS’s valuation and growth prospects, investors can access the comprehensive Pro Research Report available on InvestingPro, along with 13 additional ProTips and extensive financial metrics.
In other recent news, Krystal Biotech reported its 2024 financial results, revealing earnings per share (EPS) of $1.52 for the fourth quarter and $3.00 for the full year. These figures were slightly below some analyst projections, which had anticipated $1.81 for the quarter and $3.31 for the year. The company’s total revenue for its product VYJUVEK was $91.1 million for the fourth quarter and $290.5 million for the year, also falling short of expectations. Despite these minor misses, Krystal Biotech ended the year with a strong cash position, totaling $749.6 million. Additionally, H.C. Wainwright reaffirmed its Buy rating for Krystal Biotech, maintaining a price target of $221, reflecting confidence in the company’s growth potential. The firm highlighted the success of VYJUVEK, which is expected to drive long-term growth, especially with upcoming launches in Europe and Japan. The company also announced plans for international expansion, with the first European launch in Germany expected by mid-2025, followed by France. Moreover, Krystal Biotech is progressing with its pipeline, including new product developments and anticipated regulatory decisions in Japan.
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