BioCryst Announces Q1 2024 Financial Results and Business Update

BioCryst Pharmaceuticals Inc. (Nasdaq:BCRX) reported its financial outcomes for the first quarter that ended March 31, 2024, alongside a corporate update. The company has showcased a robust start to the year, marked by a notable increase in ORLADEYO revenue and promising advancements in its pipeline programs.

Key highlights include a 30% year-over-year (y-o-y) growth in ORLADEYO net revenue, reaching $88.9 million in Q1 2024. The U.S. commercial team significantly improved the process for annual reimbursement reauthorization, leading to quicker transitions from free to paid drugs, which contributed to higher-than-expected revenues. New patient growth in the U.S. remained robust, with the last two quarters witnessing the highest number of new prescriptions since the drug's launch. Additionally, international sales accounted for 10% of global ORLADEYO net revenues in Q1, with strong and consistent patient growth in new and existing markets.

The company plans to present new real-world evidence demonstrating significant reductions in healthcare resource utilization among hereditary angioedema (HAE) patients using ORLADEYO at the 2024 International Society for Pharmacoeconomics and Outcomes Research conference.

BioCryst's rare disease pipeline aims to bring highly differentiated products to market, emulating ORLADEYO's commercial success. Key milestones for the upcoming months include the ongoing proof-of-concept trial with BCX10013, an oral Factor D inhibitor. The company plans to either partner with another entity or discontinue this program later in the year. Additionally, the APeX-P pediatric trial enrollment is complete, and its data will support a regulatory filing in 2025 to extend the ORLADEYO label to children as young as two years old, potentially making it the first oral prophylactic therapy for children with HAE.

Other pipeline advancements include BCX17725, a KLK-5 inhibitor for Netherton syndrome, expected to enter clinical trials by the end of 2024. Netherton syndrome is a rare genetic condition characterized by red, scaly skin and frequent infections, particularly dangerous during infancy. Currently, there are no approved treatments for this condition.

In 2025, BioCryst aims to progress avoralstat into clinical trials for diabetic macular edema (DME), a leading cause of vision loss in diabetics. By using Clearside’s SCS microinjector® to deliver avoralstat into the eye, the drug could inhibit plasma kallikrein at edema sites and persist for long durations, potentially reducing the frequency of injections needed.

Financially, BioCryst reported total revenues of $92.8 million for Q1 2024, compared to $68.8 million in Q1 2023, marking a 34.9% increase y-o-y. This growth was primarily driven by the rise in ORLADEYO net revenue. Research and development (R&D) expenses decreased slightly to $46.5 million, attributed to reduced spending on BCX10013 and the discontinuation of the BCX9930 program. However, this was partially offset by increased investment in BCX17725 and other ongoing programs. Selling, general, and administrative (SG&A) expenses saw an increase to $59.4 million, driven by efforts to expand the U.S. commercial team and support international operations.

The company reported an operating loss of $14.5 million for Q1 2024, which adjusted to $0.8 million when excluding non-cash stock compensation. Interest expenses decreased by 10.6% y-o-y to $24.5 million, mainly due to reduced amortization of interest associated with royalty financing obligations. Net loss for the quarter was $35.4 million, or $0.17 per share, compared to a net loss of $53.3 million, or $0.28 per share, in Q1 2023.

BioCryst ended Q1 2024 with $338.4 million in cash, cash equivalents, restricted cash, and investments. The company anticipates total cash at the end of 2024 to be above $300 million, following a disciplined approach to capital allocation. The company has adjusted its full-year 2024 ORLADEYO revenue guidance to $390-$400 million. Operating expenses for 2024 are expected to remain flat compared to 2023, between $365 million and $375 million. BioCryst is optimistic about achieving a full-year operating profit in 2024, excluding non-cash stock compensation, and aims to be profitable on an earnings per share basis by 2026, without needing to raise additional funds.