On August 3, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, BioCryst Pharmaceuticals, AUG 3, 2023, View Source [SID1234633739]).
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"Our strong second quarter keeps us firmly on track to achieve no less than $320 million in ORLADEYO revenue this year, as our base of patients grows larger and larger every quarter. While ORLADEYO revenues continue to grow, we are also excited to host an R&D day in November to introduce new molecules and programs from our discovery platform that have the potential to replicate or exceed the success of ORLADEYO," 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
"The significant step-up in revenue we expected and achieved in the second quarter reflects the continued strong growth in patients taking ORLADEYO, the normal seasonality in revenue that follows first quarter prescription reauthorizations, and our steady improvement in helping patients get to reimbursed therapy. We recently attended the HAEA summit, attended by 1,200 patients and family members. Their strong interest and enthusiasm gave us even more confidence in our expectations for sustained long-term demand for ORLADEYO in the U.S. and globally," said Charlie Gayer, chief commercial officer of BioCryst.
ORLADEYO net revenue in the second quarter of 2023 was $81.0 million (+24.2 percent year-over-year (y-o-y)).
Total growth in patients taking ORLADEYO continued on a strong, linear trajectory.
The percentage of U.S. ORLADEYO patients receiving paid drug improved in the second quarter as the company made progress converting commercially-insured patients who had been receiving long-term free product, and as patients who received temporary free product during the first quarter prescription re-authorization process returned to reimbursed product in the second quarter.
Sales from outside the U.S. contributed 10.1 percent of global ORLADEYO net revenues in the second quarter.
The ongoing APeX-P trial in pediatric HAE patients who are 2 to <12 years of age continues to enroll as expected.
BCX10013—Oral Factor D Inhibitor
"Our goal with BCX10013 is to bring a best-in-class molecule to physicians and patients. That means a safe, highly effective, once-daily oral therapy, and we are now focused on preparing for enrollment in our dose-ranging trial in patients," said Dr. Helen Thackray, chief research and development officer.
The company has begun opening clinical trial sites for a dose-ranging trial in patients with paroxysmal nocturnal hemoglobinuria (PNH) and expects to begin patient enrollment (in countries without other approved therapies) by the end of the year. The trial is designed to identify a safe, effective, once-daily dose that BioCryst can advance into a pivotal program in renal complement-mediated diseases.
The company also plans to complete an additional cohort of its multiple ascending dose trial (MAD) of BCX10013, at a higher dose (160 mg QD), in healthy volunteers to provide further information to the pharmacokinetic model.
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 Research Center of Excellence in Birmingham, AL (the event also will be webcast live). At the R&D day, the company plans to introduce additional assets from its pipeline targeting rare diseases.
Second Quarter 2023 Financial Results
For the three months ended June 30, 2023, total revenues were $82.5 million, compared to $65.5 million in the second quarter of 2022 (+25.9 percent year-over-year (y-o-y)). The increase was primarily due to $81.0 million in ORLADEYO net revenue in the second quarter of 2023, compared to $65.2 million in ORLADEYO net revenue in the second quarter of 2022 (+24.2 percent y-o-y).
R&D expenses for the second quarter of 2023 decreased to $51.2 million from $62.0 million in the second quarter of 2022 (-17.3 percent y-o-y), primarily due to decreased investment in both the BCX9250 and complement programs, partially offset by increased investment in the early-stage pipeline.
Selling, general and administrative expenses for the second quarter of 2023 increased to $51.0 million, compared to $38.0 million in the second quarter of 2022 (+34.1 percent y-o-y). The increase was primarily due to increased investment to support the commercial launch of ORLADEYO and expanded international operations.
Interest expense was $28.9 million in the second quarter of 2023, compared to $24.0 million in the second quarter of 2022 (+20.4 percent y-o-y). The increase is primarily driven by additional interest to service the Pharmakon debt secured in April 2023.
Net loss for the second quarter of 2023 was $75.3 million, or $0.40 per share, compared to a net loss of $58.9 million, or $0.32 per share, for the second quarter of 2022. There was a $29.0 million one-time debt extinguishment fee related to the close-out of the Athyrium debt facility. Excluding this one-time event, non-GAAP net loss for the second quarter of 2023 was $0.24 per share.
Cash, cash equivalents, restricted cash and investments totaled $415.7 million at June 30, 2023, compared to $418.9 million at June 30, 2022. Operating cash use for the second quarter of 2023 was $13.5 million.
Non-GAAP Pro forma Financial Measures
The information furnished in this release includes non-GAAP pro forma financial measures that differ from measures calculated in accordance with generally accepted accounting principles in the United States of America (GAAP), including financial measures labeled as "non-GAAP" or "adjusted."
We believe providing these non-GAAP measures, which show our pro forma results with these items adjusted, is valuable and useful since they allow the company and investors to better understand the company’s financial performance in the absence of these one-time events and allow investors to more accurately understand our second quarter 2023 results and more easily compare them to future results. These non-GAAP pro forma measures also correspond with the way we expected Wall Street analysts to compare our results. Our non-GAAP pro forma measures should be considered only as supplements to, and not as substitutes for or in isolation from, our other measures of financial information prepared in accordance with GAAP, such as GAAP revenue, operating income, net income, and earnings per share.
Our references to our second quarter 2023 and first six months 2023 "non-GAAP pro forma" financial measures of adjusted net loss and adjusted earnings per share constitute non-GAAP financial measures. They refer to our GAAP results, adjusted to show the results without the one-time loss on the extinguishment of the Athyrium term loans.
Financial Outlook for 2023
The company expects full year 2023 global net ORLADEYO revenue to be no less than $320 million. Operating expenses for full year 2023, not including non-cash stock compensation, are expected to be flat to 2022 at approximately $375 million. While flat year-over-year, we expect reductions in R&D spending in 2023 following the discontinuation of the BCX9930 and BCX9250 programs in 2022 and the delay in the BCX10013 clinical program, offset by increases in SG&A to support the U.S. launch and global expansion of ORLADEYO.
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.