On November 2, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported its financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, BioCryst Pharmaceuticals, NOV 2, 2023, View Source [SID1234636737]).

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"With nearly three years of launch data, we have excellent visibility into the pattern of growth for ORLADEYO and we remain on track to achieve the no less than $320 million in ORLADEYO revenues we have expected for 2023. Our solid base and the consistent addition of new patients each quarter, combined with the ongoing improvement in our percentage of paid patients and launches in new global markets, are all driving peak revenues to $1 billion," said Jon Stonehouse, president and chief executive officer of BioCryst.

Program Updates

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

"Strong, steady new patient switches continue to fuel the growth in ORLADEYO as more and more patients want to experience the benefits of the only oral, once-daily therapy to prevent HAE attacks," said Charlie Gayer, chief commercial officer of BioCryst.

ORLADEYO net revenue in the third quarter of 2023 was $85.7 million (+29.8 percent year-over-year (y-o-y)).

Total growth in patients taking ORLADEYO continued on a strong, linear trajectory.

The ongoing APeX-P trial in pediatric HAE patients who are 2 to <12 years of age continues to enroll as expected.

Sales from outside the U.S. contributed 12.2 percent of global ORLADEYO net revenues in the third quarter.

Austria has approved the reimbursement of ORLADEYO for the targeted prophylaxis of hereditary angioedema (HAE) in patients 12 years of age or older.
Upcoming R&D Day—November 3, 2023

BioCryst will host a Research and Development (R&D) Day at 1:00p ET on Friday, November 3 at its Discovery Center of Excellence in Birmingham, AL. At the R&D Day, the company plans to describe its drug discovery process and introduce additional therapies from its pipeline. The live webcast and replay of the R&D Day will be available online in the investors section of the company website at www.biocryst.com.

Third Quarter 2023 Financial Results

For the three months ended September 30, 2023, total revenues were $86.7 million, compared to $75.8 million in the third quarter of 2022 (+14.4 percent y-o-y). The increase was primarily due to an increase in ORLADEYO net revenue of $19.7 million, partially offset by a reduction in RAPIVAB (peramivir injection) revenue of $8.8 million, compared to the third quarter of 2022.

Research and development expenses for the third quarter of 2023 decreased to $46.9 million from $52.7 million in the third quarter of 2022 (-11.0 percent y-o-y), primarily due to the discontinuations of the BCX9930 and BCX9250 programs, partially offset by additional investment in BCX10013 and pipeline programs.

Selling, general and administrative expenses for the third quarter of 2023 increased to $50.7 million, compared to $36.9 million in the third quarter of 2022 (+37.1 percent y-o-y). The increase was primarily due to increased investment to support the commercial launch of ORLADEYO.

Interest expense was $27.3 million in the third quarter of 2023, compared to $24.8 million in the third quarter of 2022 (+10.1 percent y-o-y). The increase was due to additional interest to service the Pharmakon debt secured in April 2023.

Net loss for the third quarter of 2023 was $36.1 million, or $0.19 per share, compared to a net loss of $42.5 million, or $0.23 per share, for the third quarter of 2022.

Cash, cash equivalents, restricted cash and investments totaled $399.2 million at September 30, 2023, compared to $462.6 million at September 30, 2022. Operating cash use for the third quarter of 2023 was $16.5 million (-43.9 percent y-o-y).

Financial Outlook for 2023

The company expects full year 2023 global net ORLADEYO revenue to be no less than $320 million. The company continues to be disciplined in its approach to capital allocation and is reducing its outlook for operating expenses for full year 2023, not including non-cash stock compensation, to between $365 million and $375 million, reflecting an expected decline from 2022 operating expenses.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 1-866-777-2509 for domestic callers and 1-412-317-5413 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.