— Total net revenue of
— Operating profit of
— Maintained Full Year 2026 ORLADEYO revenue guidance of
— Began shipping ORLADEYO oral pellets to pediatric patients on
— Completed enrollment in ALPHA-ORBIT, the ongoing pivotal study of navenibart —
“We were pleased to deliver strong revenue growth and positive free cash flow again in the second quarter, reflecting our continued focus on expanding the reach of ORLADEYO while advancing our prioritized pipeline programs,” said
“Across our pipeline, we completed enrollment in our pivotal navenibart trial and continued to advance BCX17725 toward early clinical data in patients by year-end. As we announced in June, we have rationalized our internal R&D efforts to better align our cost structure with our shift toward external innovation to build our pipeline. These changes will allow us to more efficiently allocate capital toward compelling assets where we have differentiated clinical and commercial expertise.
“Building on this momentum, we remain focused on cost discipline while directing our capital and energy toward opportunities where we can have the greatest impact. This positions BioCryst exceptionally well to continue delivering growth, strong profitability, and lasting value for patients and their families as well as our shareholders.”
Business & Corporate Updates
- To support the growing scale of ORLADEYO across both adults and pediatrics, BioCryst has engaged CareMed to serve as its new commercial pharmacy partner. CareMed is a full-service specialty pharmacy that provides expert care to patients living with rare diseases, and will become BioCryst’s sole source specialty pharmacy for ORLADEYO shipments to patients beginning in Q3 2026.
- New patient prescriptions maintained momentum in Q2 2026, driving ORLADEYO revenue of
$158.2 million (+1% y-o-y; +10% y-o-y on a comparable basis excluding European revenue). - Initial product shipments of ORLADEYO oral pellets to patients began the week of
August 3 , marking a new paradigm in the treatment ofHAE in pediatrics. Prescription demand is strong: 47 prescriptions have been written year-to-date. Over half of these prescriptions have completed the prior authorization process and have a high approval rate. - Patient enrollment in ALPHA-ORBIT, the ongoing pivotal study of navenibart in hereditary angioedema, was completed in June. Navenibart is an investigational, long-acting plasma kallikrein inhibitor being studied with every three-month and every six-month subcutaneous dosing. The program remains on track to report top-line results from both doses in Q3 2027.
- The company is studying BCX17725, an investigational KLK5 inhibitor for the treatment of Netherton syndrome, in a Phase 1 trial. The company is 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 June, the company announced the discontinuation of its internal discovery programs and closure of its Birmingham facility by the end of 2026 to sharpen its scientific focus on external innovation.
- In July, the company appointed David W. Jenkins, MA, PhD, as Chief Scientific Officer, strengthening the company's research leadership and external innovation strategy.
Second Quarter 2026 Financial Results
Total revenues were
Research and development expenses, excluding stock-based compensation expense, were
Sales and marketing expenses, excluding stock-based compensation expense, were
The company recorded a GAAP operating profit of
During Q2 2026, the company generated positive cash flow even when excluding the upfront consideration received from the navenibart licensing agreement. As a result, cash, cash equivalents, restricted cash and investments totaled
The accompanying tables provide GAAP and non-GAAP financial information for the three and six months ended
Financial Outlook for 2026
The company maintained its outlook for full year 2026 global net ORLADEYO revenue of
In June, the company improved its outlook for full year 2026 non-GAAP operating expenses, excluding stock-based compensation, restructuring, and transaction-related costs, to
| Item | As of | As of |
| ORLADEYO revenue | Unchanged | |
| Total revenue | ||
| Non-GAAP operating expense | ||
Conference Call and Webcast
BioCryst management will host a conference call and webcast at
About BioCryst Pharmaceuticals
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 therapeutics for 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 the United States of America (“GAAP”), including financial measures labeled as “non-GAAP.” As noted under “Second 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 related to future profitability, expectations regarding pipeline development, including expected data reporting timing, potential future milestone payments or royalties, expectations regarding BioCryst’s strategic shift to prioritize external innovation, including as it relates to future growth, value creation and opportunities, and expectations related to the closure of BioCryst’s Birmingham research facility and wind-down of internal discovery programs, including statements about the expected timing and financial impact. 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; BioCryst’s ability to successfully transition to its new sole source specialty pharmacy for ORLADEYO shipments to patients and to continue to successfully commercialize ORLADEYO, including the successful launch of the ORLADEYO oral pellet formulation; uncertainties related to BioCryst’s ability to successfully execute its plan to close the Birmingham research facility and wind-down its internal discovery programs, including the timing and costs of such action; 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
BIOCRYST PHARMACEUTICALS, INC.
CONSOLIDATED FINANCIAL SUMMARY
(In thousands, except per share)
Statements of Operations (Unaudited)
| Three Months Ended | Six Months Ended | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Revenues: | |||||||||||||||
| ORLADEYO | $ | 158,202 | $ | 156,837 | $ | 306,549 | $ | 291,080 | |||||||
| License and other revenues | 60,048 | 6,516 | 68,114 | 17,807 | |||||||||||
| Total revenues | 218,250 | 163,353 | 374,663 | 308,887 | |||||||||||
| Expenses: | |||||||||||||||
| Cost of product sales | 3,840 | 2,798 | 9,217 | 7,366 | |||||||||||
| Acquired in-process research and development | — | — | 697,761 | — | |||||||||||
| Research and development | 51,969 | 43,386 | 112,288 | 80,656 | |||||||||||
| Selling, general and administrative | 63,976 | 87,383 | 158,530 | 169,852 | |||||||||||
| Total operating expenses | 119,785 | 133,567 | 977,796 | 257,874 | |||||||||||
| Income (loss) from operations | 98,465 | 29,786 | (603,133 | ) | 51,013 | ||||||||||
| Other income (expense): | |||||||||||||||
| Interest income | 2,434 | 2,516 | 4,690 | 5,540 | |||||||||||
| Interest expense | (21,712 | ) | (21,582 | ) | (41,491 | ) | (45,076 | ) | |||||||
| Foreign currency gains (losses), net | 27 | (63 | ) | (198 | ) | (62 | ) | ||||||||
| Loss on extinguishment of debt | — | (4,171 | ) | — | (4,171 | ) | |||||||||
| Other income (expense), net | 260 | — | (1,202 | ) | — | ||||||||||
| Total other expense, net | (18,991 | ) | (23,300 | ) | (38,201 | ) | (43,769 | ) | |||||||
| Income (loss) before income taxes | 79,474 | 6,486 | (641,334 | ) | 7,244 | ||||||||||
| Income tax expense | 1,079 | 1,401 | 2,083 | 2,127 | |||||||||||
| Net income (loss) | $ | 78,395 | $ | 5,085 | $ | (643,417 | ) | $ | 5,117 | ||||||
| Net income (loss) per common share: basic | $ | 0.31 | $ | 0.02 | $ | (2.59 | ) | $ | 0.02 | ||||||
| Weighted average shares of common stock outstanding: basic | 254,481 | 209,519 | 248,403 | 209,203 | |||||||||||
| Net income (loss) per common share: diluted | $ | 0.30 | $ | 0.02 | $ | (2.59 | ) | $ | 0.02 | ||||||
| Weighted average shares of common stock outstanding: diluted | 265,165 | 219,886 | 248,403 | 217,574 | |||||||||||
Balance Sheet Data (in thousands)
(unaudited) | (Note 1) | ||||||
| Cash, cash equivalents and investments | $ | 352,573 | $ | 335,911 | |||
| Restricted cash | 1,412 | 1,601 | |||||
| Receivables | 110,757 | 106,818 | |||||
| Total assets | 557,851 | 514,158 | |||||
| Secured term loan | 395,400 | — | |||||
| Royalty financing obligation | 426,789 | 465,688 | |||||
| Accumulated deficit | (2,149,596 | ) | (1,506,179 | ) | |||
| Stockholders’ deficit | (454,289 | ) | (119,153 | ) | |||
| Shares of common stock outstanding | 255,265 | 213,060 | |||||
| Note 1: Derived from audited financial statements. | |||||||
Reconciliations of Non-GAAP Income from Operations (in thousands)
| Three Months Ended | |||||||||
| Non-GAAP Adjustments | Non-GAAP | ||||||||
| Revenues: | |||||||||
| ORLADEYO | $ | 158,202 | $ | — | $ | 158,202 | |||
| License and other revenues | 60,048 | — | 60,048 | ||||||
| Total revenues | 218,250 | — | 218,250 | ||||||
| Expenses: | |||||||||
| Cost of product sales - ORLADEYO | 3,737 | — | 3,737 | ||||||
| Cost of product sales - peramivir | 103 | — | 103 | ||||||
| Research and development (excluding stock-based compensation) | 46,496 | — | 46,496 | ||||||
| Sales and marketing (excluding stock-based compensation) | 33,947 | — | 33,947 | ||||||
| General and administrative (excluding stock-based compensation) | 20,810 | — | 20,810 | ||||||
| Stock-based compensation | 14,692 | 14,692 | — | ||||||
| Total operating expenses | 119,785 | 14,692 | 105,093 | ||||||
| Income (loss) from operations | $ | 98,465 | $ | (14,692 | ) | $ | 113,157 | ||
| Three Months Ended | |||||||||
| Non-GAAP Adjustments1 | Non-GAAP | ||||||||
| Revenues: | |||||||||
| ORLADEYO | $ | 156,837 | $ | 13,310 | $ | 143,527 | |||
| License and other revenues | 6,516 | — | 6,516 | ||||||
| Total revenues | 163,353 | 13,310 | 150,043 | ||||||
| Expenses: | |||||||||
| Cost of product sales - ORLADEYO | 2,388 | 1,080 | 1,308 | ||||||
| Cost of product sales - peramivir | 410 | — | 410 | ||||||
| Research and development (excluding stock-based compensation) | 34,059 | 1,286 | 32,773 | ||||||
| Sales and marketing (excluding stock-based compensation) | 45,589 | 12,165 | 33,424 | ||||||
| General and administrative (excluding stock-based compensation) | 29,817 | 8,577 | 21,240 | ||||||
| Stock-based compensation | 21,304 | 21,304 | — | ||||||
| Total operating expenses | 133,567 | 44,412 | 89,155 | ||||||
| Income from operations | $ | 29,786 | $ | (31,102 | ) | $ | 60,888 | ||
| 1Reflects the following non-GAAP adjustments for the three months ended | |||||||||
| Revenues and expenses associated with our European ORLADEYO business which was sold to | |||||||||
| ORLADEYO revenue | $ | 13,310 | |||||||
| Cost of product sales - ORLADEYO | $ | 1,080 | |||||||
| Research and development (excluding stock-based compensation) | $ | 1,286 | |||||||
| Sales and marketing (excluding stock-based compensation) | $ | 12,165 | |||||||
| General and administrative (excluding stock-based compensation) | $ | 2,689 | |||||||
| Transaction-related costs associated with the sale of our European ORLADEYO to | $ | 5,888 | |||||||
| Stock-based compensation | $ | 21,304 | |||||||
| Six Months Ended | ||||||||||
| Non-GAAP Adjustments1 | Non-GAAP | |||||||||
| Revenues: | ||||||||||
| ORLADEYO | $ | 306,549 | $ | — | $ | 306,549 | ||||
| License and other revenues | 68,114 | — | 68,114 | |||||||
| Total revenues | 374,663 | — | 374,663 | |||||||
| Expenses: | ||||||||||
| Cost of product sales - ORLADEYO | 6,433 | — | 6,433 | |||||||
| Cost of product sales - peramivir | 2,784 | — | 2,784 | |||||||
| Acquired in-process research and development | 697,761 | 697,761 | — | |||||||
| Research and development (excluding stock-based compensation) | 99,996 | 15,480 | 84,516 | |||||||
| Sales and marketing (excluding stock-based compensation) | 76,900 | 5,482 | 71,418 | |||||||
| General and administrative (excluding stock-based compensation) | 63,203 | 21,088 | 42,115 | |||||||
| Stock-based compensation | 30,719 | 30,719 | — | |||||||
| Total operating expenses | 977,796 | 770,530 | 207,266 | |||||||
| (Loss) income from operations | $ | (603,133 | ) | $ | (770,530 | ) | $ | 167,397 | ||
| 1Reflects the following non-GAAP adjustments for the six months ended | ||||||||||
| Expenses incurred in connection with the acquisition of | ||||||||||
| 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 | $ | 30,719 | ||||||||
| Six Months Ended | |||||||||
| Non-GAAP Adjustments1 | Non-GAAP | ||||||||
| Revenues: | |||||||||
| ORLADEYO | $ | 291,080 | $ | 24,846 | $ | 266,234 | |||
| License and other revenues | 17,807 | — | 17,807 | ||||||
| Total revenues | 308,887 | 24,846 | 284,041 | ||||||
| Expenses: | |||||||||
| Cost of product sales - ORLADEYO | 4,382 | 1,745 | 2,637 | ||||||
| Cost of product sales - peramivir | 2,984 | — | 2,984 | ||||||
| Research and development (excluding stock-based compensation) | 62,801 | 1,443 | 61,358 | ||||||
| Sales and marketing (excluding stock-based compensation) | 93,259 | 21,358 | 71,901 | ||||||
| General and administrative (excluding stock-based compensation) | 51,776 | 11,544 | 40,232 | ||||||
| Stock-based compensation | 42,672 | 42,672 | — | ||||||
| Total operating expenses | 257,874 | 78,762 | 179,112 | ||||||
| Income from operations | $ | 51,013 | $ | (53,916 | ) | $ | 104,929 | ||
| 1Reflects the following non-GAAP adjustments for the six months ended | |||||||||
| Revenues and expenses associated with our European ORLADEYO business which was sold to | |||||||||
| ORLADEYO revenue | $ | 24,846 | |||||||
| Cost of product sales - ORLADEYO | $ | 1,745 | |||||||
| Research and development (excluding stock-based compensation) | $ | 1,443 | |||||||
| Sales and marketing (excluding stock-based compensation) | $ | 21,358 | |||||||
| General and administrative (excluding stock-based compensation) | $ | 5,106 | |||||||
| Transaction-related costs associated with the sale of our European ORLADEYO to | $ | 6,438 | |||||||
| Stock-based compensation | $ | 42,672 | |||||||
