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  4. [8-K] BIOCRYST PHARMACEUTICALS INC Reports Material Event

BioCryst (NASDAQ: BCRX) posts $601M 2025 ORLADEYO revenue, up 37%

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

BioCryst Pharmaceuticals reported preliminary, unaudited full-year 2025 net revenue from its hereditary angioedema drug ORLADEYO of $601 million, which the company highlighted as a 37 percent year-over-year increase and above its prior guidance range. The company also discussed non-GAAP views of ORLADEYO sales that exclude European revenue to show comparable growth, noting 36 percent growth for the fourth quarter of 2025 and 43 percent growth for the full year 2025 on this basis. In the same update, BioCryst provided guidance for 2026 ORLADEYO net revenue, total revenue, and operating expenses, and reminded investors of its presentation at the J.P. Morgan Healthcare Conference.

Positive

  • Preliminary 2025 ORLADEYO net revenue reached $601 million, a 37% year-over-year increase that the company states is above its prior guidance range.
  • Comparable-growth metrics show ORLADEYO net revenue rising 36% year over year in Q4 2025 and 43% for full-year 2025 after excluding specified European revenue.

Negative

  • None.

Insights

Strong ORLADEYO growth with 2025 revenue above prior guidance.

BioCryst disclosed preliminary 2025 ORLADEYO net revenue of $601 million, which it described as a 37% year-over-year increase and above its prior guidance range. This indicates robust uptake of its lead hereditary angioedema therapy and suggests commercial execution exceeded the company’s earlier expectations.

The company also emphasized non-GAAP growth metrics that exclude European ORLADEYO revenue to create a comparable base. Using these measures, it cited 36% year-over-year growth for fourth quarter 2025 and 43% for full-year 2025, after backing out specified European revenue amounts from 2024 and 2025. This framing focuses attention on underlying demand outside Europe.

BioCryst additionally provided guidance ranges for 2026 ORLADEYO net revenue, total revenue, and operating expenses and highlighted its presentation at the January 12, 2026 J.P. Morgan Healthcare Conference. Future detailed filings will show how its 2026 performance tracks against these new benchmarks.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What preliminary 2025 ORLADEYO revenue did BioCryst (BCRX) report?

BioCryst reported preliminary, unaudited full-year 2025 ORLADEYO (berotralstat) net revenue of $601 million, which it described as a 37 percent year-over-year increase and above its prior guidance range.

How fast is ORLADEYO revenue growing at BioCryst (BCRX)?

Using GAAP figures, the company highlighted 37 percent year-over-year growth in ORLADEYO net revenue to $601 million in 2025. On a non-GAAP comparable basis that excludes specified European revenue, it cited 36 percent growth for fourth quarter 2025 and 43 percent growth for the full year 2025.

Why does BioCryst use non-GAAP ORLADEYO revenue measures?

BioCryst explains that its non-GAAP ORLADEYO revenue measures adjust GAAP results to exclude certain European revenue amounts. The company believes this helps management and investors better understand its performance without the impact of these items and more easily compare current results to past and future periods.

What specific adjustments does BioCryst make to ORLADEYO revenue for non-GAAP metrics?

For 2025, the non-GAAP ORLADEYO revenue measure excludes $38 million of European ORLADEYO revenue for the nine months ended September 30, 2025. The comparable growth calculations also exclude $13 million of European ORLADEYO revenue from fourth quarter 2024 and $43 million from full-year 2024.

Did BioCryst (BCRX) provide any outlook or guidance for 2026 in this update?

Yes. The company stated that it provided guidance for full-year 2026 ORLADEYO net revenue, total revenue, and operating expenses in the same communication that included the preliminary 2025 ORLADEYO revenue figures.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 8-K

_________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  January 12, 2026

_______________________________

BioCryst Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

_______________________________

Delaware000-2318662-1413174
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification No.)

4505 Emperor Blvd., Suite 200

Durham, North Carolina 27703

(Address of Principal Executive Offices) (Zip Code)

(919) 859-1302

(Registrant's telephone number, including area code)

 

(Former name or former address, if changed since last report)

_______________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common StockBCRXNasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 
 
Item 2.02. Results of Operations and Financial Condition.

 

On January 12, 2026, BioCryst Pharmaceuticals, Inc. (the “Company”) issued a press release (the “Press Release”) announcing, among other things, preliminary, unaudited ORLADEYO® (berotralstat) net revenue for the fourth quarter and full year ended December 31, 2025. The Company also provided guidance for full year 2026 ORLADEYO net revenue, total revenue, and operating expenses. The Press Release also referenced a previously announced, upcoming webcast presentation by the Company at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on January 12, 2026 at 1:30 p.m. ET. A copy of the Press Release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

 

Item 7.01. Regulation FD Disclosure.

 

The information furnished on Exhibit 99.1 is incorporated by reference under this Item 7.01 as if fully set forth herein.

 

The information in Items 2.02 and 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 furnished hereby, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 8.01. Other Events.

 

As announced in the Press Release:

 

 ·Preliminary, unaudited ORLADEYO net revenue in the fourth quarter of 2025 was $151 million (+22 percent year-over-year; +36% year-over-year on a comparable basis, excluding European ORLADEYO revenue for the fourth quarter of 2024).  

 

 ·Preliminary, unaudited ORLADEYO net revenue for full year 2025 was $601 million (+37 percent year-over-year). Excluding European ORLADEYO revenue for the full year 2025, preliminary, unaudited ORLADEYO net revenue was $563 million (+43 percent year-over-year on a comparable basis).

 

 ·Preliminary, unaudited cash, cash equivalents, restricted cash & investments as of December 31, 2025, were $338 million.

 

Non-GAAP Financial Measures

 

The information above includes non-GAAP financial measures that differ from measures calculated in accordance with generally accepted accounting principles in the United States of America (“GAAP”).

 

The Company believes providing these non-GAAP measures, which show its results with these items adjusted, is valuable and useful since they allow management and investors to better understand the Company’s financial performance in the absence of certain special events and allow investors to more accurately understand the Company’s current and past period results and more easily compare them to future results. These non-GAAP measures also correspond with the way the Company expects investors and financial analysts to compare its results. The Company’s non-GAAP measures should be considered only as supplements to, and not as substitutes for or in isolation from, its other measures of financial information prepared in accordance with GAAP, such as GAAP revenue.

 

The Company’s references to the “non-GAAP” financial measure of preliminary, unaudited 2025 ORLADEYO revenue, excluding European ORLADEYO revenue for the full year 2025, constitutes a non-GAAP financial measure. It refers to the Company’s preliminary GAAP results, adjusted to show the results without including $38 million of European ORLADEYO revenue for the nine months ended September 30, 2025. The Company’s measure of 36% year-over-year growth on a comparable basis for preliminary, unaudited ORLADEYO net revenue in the fourth quarter of 2025 was calculated using the non-GAAP financial measure of fourth quarter 2024 ORLADEYO net revenue, adjusted to exclude $13 million of European ORLADEYO revenue for the three months ended December 31, 2024. The Company’s measure of 43% year-over-year growth on a comparable basis for preliminary, unaudited ORLADEYO net revenue for the full year 2025 was calculated using the non-GAAP financial measure of full year 2024 ORLADEYO net revenue, adjusted to exclude $43 million of European ORLADEYO revenue for the twelve months ended December 31, 2024.

 

Cautionary Statement Regarding Forward-Looking Statements

 

This document contains forward-looking statements, including statements regarding preliminary, unaudited results. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance, or achievements to be materially different from any preliminary, unaudited results, performance, or achievements. These statements reflect the Company’s current views and are based on assumptions and subject to risks and uncertainties, including those described in the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No. Description
   
99.1 Press release dated January 12, 2026 entitled “BioCryst Announces Preliminary Full Year 2025 ORLADEYO® (berotralstat) Net Revenue of $601 Million (+37 percent y-o-y), Beating Prior Guidance Range”
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 BioCryst Pharmaceuticals, Inc.
   
  
Date: January 12, 2026By: /s/ Alane Barnes        
  Alane Barnes
  Chief Legal Officer
  

 

Source: View Original Filing on SEC EDGAR