— Q1 2026 ORLADEYO® net revenue of
— Announced licensing agreement for European commercial rights to navenibart for
“We began 2026 with continued strong execution across our business, led by sustained growth of ORLADEYO and solid progress across our pipeline,” said
Business & Corporate Updates
- New patient prescriptions in Q1 2026 continued to be strong, driving ORLADEYO revenue of
$148.3 million (+11% y-o-y; +21% y-o-y on a comparable basis excluding European revenue). - Patient enrollment in ALPHA-ORBIT, the ongoing pivotal study of navenibart in hereditary angioedema, is on track to be completed by the end of this June. The program remains on track to support regulatory filing in the US by the end of 2027. Navenibart is an investigational, long-acting plasma kallikrein inhibitor being studied with every three-month and every six-month subcutaneous dosing.
- In May, the company announced that it entered into a licensing agreement with an Irish affiliate of
Neopharmed Gentili for exclusive rights to commercialize navenibart inEurope for the prophylaxis of hereditary angioedema. BioCryst will receive upfront consideration of$70M and will be eligible to receive up to$275M in future regulatory and sales milestone payments. BioCryst will also receive tiered royalties on net sales ranging from 18% to 30%. Navenibart is an investigational product that has not yet received regulatory approval in the US orEurope . - The company is studying BCX17725, an investigational KLK5 inhibitor for the treatment of Netherton syndrome, in a Phase 1 trial. The company has begun dosing in Part 4 of this trial, which will enroll up to 12 patients for three months, and expects to report data from this part by the end of 2026.
- In Q1 2026, the company ended development of avoralstat, a plasma kallikrein inhibitor for the treatment of diabetic macular edema, to focus the pipeline on rare diseases.
- In April, the company appointed
Sandeep M. Menon as Chief Research and Development Officer.Dr. Menon brings deep drug development expertise to the leadership team and will lead the company’s R&D efforts with a focused, disciplined, and capital efficient approach.
First Quarter 2026 Financial Results
On
The accompanying tables provide GAAP and non-GAAP financial information. Non-GAAP measures include adjustments, as applicable, for the sale of the European ORLADEYO business on
BioCryst recorded a GAAP operating loss of
Cash, cash equivalents, restricted cash and investments at
Financial Outlook for 2026
The company maintained its expectation for full year 2026 global net ORLADEYO revenue to be between
The company also maintained its expectation for full year 2026 non-GAAP operating expenses, excluding stock-based compensation, restructuring, and transaction-related costs, to be between
| Item | As of | As of |
| ORLADEYO revenue | Unchanged | |
| Total revenue | Unchanged | |
| Non-GAAP operating expense | Unchanged | |
Conference Call and Webcast
BioCryst management will host a conference call and webcast at
About
BioCryst is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (“HAE”) and other rare diseases, driven by its deep commitment to improving the lives of people living with these conditions. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of potential first-in-class or best-in-class oral small-molecule and injectable protein therapeutics for a range of rare diseases. For more information, please visit www.biocryst.com or follow us on LinkedIn.
Non-GAAP Financial Measures
The information furnished in this release and the accompanying tables includes non-GAAP financial measures that differ from measures calculated in accordance with generally accepted accounting principles in
As noted under “First Quarter 2026 Financial Results” above, we believe providing these non-GAAP measures, which show our results with certain items adjusted, is valuable and useful since they can provide greater transparency into the financial results of core, ongoing operations and improve comparability across reporting periods. These non-GAAP measures also correspond with the way we expect investors and financial analysts to compare our results. Our non-GAAP 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. A reconciliation between each non-GAAP financial measure and its respective closest equivalent GAAP financial measure is provided in the tables below.
We also provide our non-GAAP operating expense outlook for full year 2026, which refers to our expected GAAP operating expense, excluding stock-based compensation, restructuring and transaction-related costs. We have not provided a reconciliation against the comparable forward-looking GAAP measure because we are unable to predict with reasonable certainty the full amount of stock-based compensation expense or restructuring or transaction-related costs for the full year 2026 without unreasonable effort. Stock-based compensation expense is uncertain and depends on various factors, including our future hiring and retention needs, as well as the future fair market value of our common stock, which is difficult to predict and subject to change. In addition, we are unable to predict with reasonable certainty the full amount of restructuring and transaction-related costs as the related costs are dependent on various factors that have not yet or have only recently occurred. The actual amount of stock-based compensation, restructuring and transaction-related costs for the full year 2026 could have a material impact on GAAP reported results for the guidance period.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding future results, performance or achievements, such as expected full year 2026 revenue and operating expenses, expectations regarding pipeline development timing, including expected patient enrollment, regulatory filing, and data reporting timing, and potential future milestone payments. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: BioCryst’s ability to successfully progress its pipeline development plans as described herein, including meeting the expected timelines; ongoing and future preclinical and clinical development of product candidates may take longer than expected and may not have positive results; the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates as expected; the FDA or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may not review regulatory filings on our expected timeline, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay or withdraw market approval for products and product candidates; the results of BioCryst’s partnerships with third parties may not meet BioCryst’s current expectations, including that our partners may fail to reach performance milestones or achieve certain royalty thresholds under our license agreements; statements and projections regarding financial guidance and goals and the attainment of such goals may differ from actual results based on market factors and BioCryst’s ability to execute its operational and budget plans; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management’s expected ranges. This list is not exclusive. To see a more comprehensive list of risks, please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.
BCRXW
Contact:
Investors:
investorrelations@biocryst.com
Media:
media@biocryst.com
CONSOLIDATED FINANCIAL SUMMARY (In thousands, except per share) | |||||||
| Statements of Operations(Unaudited) | |||||||
| Three Months Ended | |||||||
| 2026 | 2025 | ||||||
| Revenues: | |||||||
| ORLADEYO | $ | 148,347 | $ | 134,243 | |||
| License revenue | 3,016 | — | |||||
| Other revenues | 5,050 | 11,291 | |||||
| Total revenues | 156,413 | 145,534 | |||||
| Expenses: | |||||||
| Cost of product sales | 5,377 | 4,568 | |||||
| Acquired in-process research and development | 697,761 | — | |||||
| Research and development | 60,319 | 37,270 | |||||
| Selling, general and administrative | 94,554 | 82,469 | |||||
| Total operating expenses | 858,011 | 124,307 | |||||
| (Loss) income from operations | (701,598 | ) | 21,227 | ||||
| Other income (expense): | |||||||
| Interest income | 2,256 | 3,024 | |||||
| Interest expense | (19,779 | ) | (23,494 | ) | |||
| Foreign currency (losses) gains, net | (225 | ) | 1 | ||||
| Other expense, net | (1,462 | ) | — | ||||
| Total other expense, net | (19,210 | ) | (20,469 | ) | |||
| (Loss) income before income taxes | (720,808 | ) | 758 | ||||
| Income tax expense | 1,004 | 726 | |||||
| Net (loss) income | $ | (721,812 | ) | $ | 32 | ||
| Net (loss) income per common share: basic | $ | (2.98 | ) | $ | 0.00 | ||
| Weighted average shares of common stock outstanding: basic | 242,258 | 208,882 | |||||
| Net (loss) income per common share: diluted | $ | (2.98 | ) | $ | 0.00 | ||
| Weighted average shares of common stock outstanding: diluted | 242,258 | 215,261 | |||||
| Balance Sheet Data (in thousands) | |||||||
(unaudited) | (Note 1) | ||||||
| Cash, cash equivalents and investments | $ | 258,969 | $ | 335,911 | |||
| Restricted cash | 1,787 | 1,601 | |||||
| Receivables | 109,272 | 106,818 | |||||
| Total assets | 465,052 | 514,158 | |||||
| Secured term loan | 395,197 | — | |||||
| Royalty financing obligation | 447,498 | 465,688 | |||||
| Accumulated deficit | (2,227,991 | ) | (1,506,179 | ) | |||
| Stockholders’ deficit | (553,843 | ) | (119,153 | ) | |||
| Shares of common stock outstanding | 254,014 | 213,060 | |||||
| Note 1: Derived from audited financial statements. | |||||||
| Reconciliations of Non-GAAP Income from Operations (in thousands) | |||||||||||
| Three Months Ended | |||||||||||
| Non-GAAP Adjustments1 | Non-GAAP | ||||||||||
| Revenues: | |||||||||||
| ORLADEYO | $ | 148,347 | $ | — | $ | 148,347 | |||||
| License revenue | 3,016 | — | 3,016 | ||||||||
| Other revenues | 5,050 | — | 5,050 | ||||||||
| Total revenues | 156,413 | — | 156,413 | ||||||||
| Expenses: | |||||||||||
| Cost of product sales - ORLADEYO | 2,696 | — | 2,696 | ||||||||
| Cost of product sales - peramivir | 2,681 | — | 2,681 | ||||||||
| Acquired in-process research and development | 697,761 | 697,761 | — | ||||||||
| Research and development (excluding stock-based compensation) | 53,500 | 15,480 | 38,020 | ||||||||
| Sales and marketing (excluding stock-based compensation) | 42,953 | 5,482 | 37,471 | ||||||||
| General and administrative (excluding stock-based compensation) | 42,393 | 21,088 | 21,305 | ||||||||
| Stock-based compensation | 16,027 | 16,027 | — | ||||||||
| Total operating expenses | 858,011 | 755,838 | 102,173 | ||||||||
| (Loss) income from operations | $ | (701,598 | ) | $ | (755,838 | ) | $ | 54,240 | |||
| 1 Reflects the following non-GAAP adjustments for the three months ended | |||||||||||
| Expenses incurred in connection with the acquisition of Astria Therapeutics, Inc. on | |||||||||||
| Acquired in-process research and development related to navenibart | $ | 697,761 | |||||||||
| Assembled workforce amortization | $ | 600 | |||||||||
| Expense associated with severance and retention award agreements | $ | 12,321 | |||||||||
| Portion of stock option payout attributable to post-combination service | $ | 29,129 | |||||||||
| Stock-based compensation | $ | 16,027 | |||||||||
| Three Months Ended | |||||||||||
| Non-GAAP Adjustments1 | Non-GAAP | ||||||||||
| Revenues: | |||||||||||
| ORLADEYO | $ | 134,243 | $ | 11,536 | $ | 122,707 | |||||
| License revenue | — | — | — | ||||||||
| Other revenues | 11,291 | — | 11,291 | ||||||||
| Total revenues | 145,534 | 11,536 | 133,998 | ||||||||
| Expenses: | |||||||||||
| Cost of product sales - ORLADEYO | 1,994 | 665 | 1,329 | ||||||||
| Cost of product sales - peramivir | 2,574 | — | 2,574 | ||||||||
| Research and development (excluding stock-based compensation) | 28,742 | 157 | 28,585 | ||||||||
| Sales and marketing (excluding stock-based compensation) | 47,670 | 9,193 | 38,477 | ||||||||
| General and administrative (excluding stock-based compensation) | 21,959 | 2,417 | 19,542 | ||||||||
| Stock-based compensation | 21,368 | 21,368 | — | ||||||||
| Total operating expenses | 124,307 | 33,800 | 90,507 | ||||||||
| Income from operations | $ | 21,227 | $ | (22,264 | ) | $ | 43,491 | ||||
| 1 Represents revenues and expenses associated with our European ORLADEYO business which was sold to | |||||||||||
