BioCryst Reports First Quarter 2023 Financial Results and Provides Business Update
- ORLADEYO net revenue grows 38% YoY to $68.4 million
- 46% increase in patients on therapy YoY
- 8% growth in patients on therapy QoQ
- Over 1,000 U.S. patients on ORLADEYO therapy
- ORLADEYO net revenue in 2023 expected to be no less than $320 million
- None.
—Q1 2023 ORLADEYO net revenue grows 38 percent y-o-y to
—Strong ORLADEYO new patient growth in Q1: 46 percent increase in patients on therapy y-o-y, including eight percent growth q-o-q—
—Over 1,000 U.S. patients on ORLADEYO therapy—
—ORLADEYO net revenue in 2023 expected to be no less than
RESEARCH TRIANGLE PARK, N.C., May 03, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported financial results for the first quarter ended March 31, 2023, and provided a corporate update.
“The strong new patient growth in the first quarter, building on our large patient base with ORLADEYO, positions us very well to achieve our expectations for 2023, and advances us on a trajectory to peak sales of
Program Updates
ORLADEYO® (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks
- ORLADEYO net revenue in the first quarter of 2023 was
$68.4 million (+37.6 percent year-over-year (y-o-y)). - The number of U.S. patients on drug at the end of Q1 2023 increased by 46 percent compared to the end of Q1 2022 and increased by eight percent compared to the end of Q4 2022.
- The launch has recently surpassed the milestone of 1,000 patients in the U.S. on ORLADEYO therapy.
- New patient growth remained strong, with a 20 percent increase in U.S. patient start forms in the first quarter of 2023 compared to the first quarter of 2022. There were more new U.S. patient start forms in the first quarter of 2023 than in three of the four quarters in 2022.
- The launch of ORLADEYO outside the U.S. continues to accelerate. Sales from outside the U.S. contributed 11.1 percent of global ORLADEYO net revenues in the first quarter.
- As expected, the percentage of U.S. ORLADEYO patients receiving free drug in the first quarter increased, primarily because many patients went through the annual re-authorization process with payors.
“As we enter our third year on the market, 1,000 of 7,500 U.S. HAE patients are already benefitting from ORLADEYO. Demand is very strong in the U.S. and in international markets and our market data from patients and physicians tells us that ORLADEYO is still in the early stages of its growth trajectory,” said Charlie Gayer, chief commercial officer of BioCryst.
Rare Disease Pipeline
The goal with our pipeline is to continue bringing selected, highly differentiated rare disease products to the market, and to reproduce the commercial success we have delivered with ORLADEYO. We are investing to expand the ORLADEYO label with our ongoing pediatric trial (APeX-P); and pursuing BCX10013, a potential best-in-class once-daily, oral Factor D inhibitor, an oral C2 inhibitor in lead optimization, and other discovery programs targeting multiple complement and non-complement pathways.
Debt Refinancing
On April 17, 2023, the company entered into a
First Quarter 2023 Financial Results
For the three months ended March 31, 2023, total revenues were
Research and development (R&D) expenses for the first quarter of 2023 decreased to
Selling, general and administrative (SG&A) expenses for the first quarter of 2023 increased to
Interest expense was
Net loss for the first quarter of 2023 was
Cash, cash equivalents, restricted cash and investments totaled
Financial Outlook for 2023
The company expects full year 2023 global net ORLADEYO revenue to be no less than
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.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO® (berotralstat) is approved in the United States and many global markets. BioCryst has active programs to develop oral medicines for multiple targets across the complement system, including BCX10013, an oral Factor D inhibitor in clinical development. RAPIVAB® (peramivir injection) is approved in the U.S. and multiple global markets, with post-marketing commitments ongoing. For more information, please visit the company’s website at www.biocryst.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. 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: the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst’s business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst’s and its partners’ development, regulatory processes and supply chains, negatively impact BioCryst’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening many of the risks described below or in the documents BioCryst files periodically with the Securities and Exchange Commission; BioCryst’s ability to successfully implement its commercialization plans for, and to commercialize, ORLADEYO, which could take longer or be more expensive than planned; the results of BioCryst’s partnerships with third parties may not meet BioCryst’s current expectations; risks related to government actions, including that decisions and other actions, including as they relate to pricing, may not be taken when expected or at all, or that the outcomes of such decisions and other actions may not be in line with BioCryst’s current expectations; the commercial viability of ORLADEYO, including its ability to achieve market acceptance; ongoing and future preclinical and clinical development of BCX10013 and other product candidates may take longer than expected and may not have positive 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 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; product candidates, if approved, may not achieve market acceptance; BioCryst’s ability to successfully commercialize its products and product candidates, manage its growth and compete effectively; risks related to the international expansion of BioCryst’s business; 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. 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:
John Bluth
+1 919 859 7910
jbluth@biocryst.com
| BIOCRYST PHARMACEUTICALS, INC. | ||||||||
| CONSOLIDATED FINANCIAL SUMMARY | ||||||||
| (in thousands, except per share) | ||||||||
| Statements of Operations (Unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenues: | ||||||||
| ORLADEYO | $ | 68,414 | $ | 49,704 | ||||
| Other | 364 | 219 | ||||||
| Total revenues | 68,778 | 49,923 | ||||||
| Expenses: | ||||||||
| Cost of product sales | 931 | 236 | ||||||
| Research and development | 48,388 | 65,360 | ||||||
| Selling, general and administrative | 47,867 | 34,282 | ||||||
| Royalty | 7 | 2 | ||||||
| Total operating expenses | 97,193 | 99,880 | ||||||
| Loss from operations | (28,415 | ) | (49,957 | ) | ||||
| Interest and other income | 3,378 | 54 | ||||||
| Interest expense | (27,396 | ) | (23,837 | ) | ||||
| Foreign currency (losses) gains, net | (229 | ) | (177 | ) | ||||
| Loss before income taxes | (52,662 | ) | (73,917 | ) | ||||
| Income tax expense | 671 | 279 | ||||||
| Net loss | $ | (53,333 | ) | $ | (74,196 | ) | ||
| Basic and diluted net loss per common share | $ | (0.28 | ) | $ | (0.40 | ) | ||
| Weighted average shares outstanding | 188,509 | 184,898 | ||||||
| Balance Sheet Data (in thousands) | |||||||
| March 31, 2023 | December 31, 2022 | ||||||
| (Unaudited) | (Note 1) | ||||||
| Cash, cash equivalents and investments | $ | 401,590 | $ | 442,387 | |||
| Restricted cash | 1,463 | 1,472 | |||||
| Receivables | 48,639 | 50,599 | |||||
| Total assets | 509,737 | 550,000 | |||||
| Secured term loan | 232,522 | 231,624 | |||||
| Royalty financing obligation | 514,411 | 501,655 | |||||
| Accumulated deficit | (1,507,953 | ) | (1,454,620 | ) | |||
| Stockholders’ deficit | (328,287 | ) | (294,597 | ) | |||
| Shares of common stock outstanding | 188,883 | 187,906 | |||||
| Note 1: Derived from audited financial statements. | |||||||
FAQ
What was the growth rate of ORLADEYO net revenue in Q1 2023?
How much is the expected ORLADEYO net revenue in 2023?
How many U.S. patients are on ORLADEYO therapy?
What was the increase in patients on therapy in Q1 2023 compared to Q1 2022?
What was the growth rate of new patient start forms in Q1 2023 compared to Q1 2022?
