SECURITIES AND EXCHANGE COMMISSION
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On November 3, 2021, BioCryst Pharmaceuticals, Inc. (the “Company”) issued a press release announcing recent corporate developments and its financial results for the third quarter ended September 30, 2021, which also referenced a conference call and webcast to discuss these recent corporate developments and financial results. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
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 this Current Report on Form 8-K 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.
|99.1||Press release dated November 3, 2021 entitled “BioCryst Reports Third Quarter 2021 Financial Results and Upcoming Key Milestones”|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
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: November 3, 2021||By:||/s/ Alane Barnes|
|Chief Legal Officer|
BioCryst Reports Third Quarter 2021 Financial Results and Upcoming Key Milestones
—3Q 2021 revenue of $41.0 million—
—ORLADEYO® (berotralstat) net revenue of $37.0 million—
—Full year 2021 ORLADEYO net revenue expected to be $115-$120 million—
RESEARCH TRIANGLE PARK, N.C., Nov. 03, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced financial results for the third quarter ended September 30, 2021, and provided a corporate update.
“With the significant revenue of $115 million to $120 million we expect to generate with ORLADEYO in its first year of launch, and an even larger fast-following pipeline that includes four separate indications currently in pivotal or proof of concept trials in the complement space with BCX9930, BioCryst plans to repeat our clinical and commercial success with ORLADEYO again and again as we bring these much-needed oral medicines to the patients who are waiting for them,” said Jon Stonehouse, president and chief executive officer of BioCryst.
Program Updates and Key Milestones
ORLADEYO® (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks
“Almost a year into the launch of ORLADEYO, we continue to see strong, consistent demand from new patients switching to ORLADEYO from their existing injectable prophylactic and acute therapies, and it is exciting to see the positive impact ORLADEYO is having on their lives. With the excellent start to the launch, and the excitement we hear from physicians and patients, ORLADEYO is now on a trajectory to become the market leader in HAE prophylaxis,” said Charlie Gayer, chief commercial officer of BioCryst.
ORLADEYO: Global Updates
Complement Oral Factor D Inhibitor Program – BCX9930
Third Quarter 2021 Financial Results
For the three months ended September 30, 2021, total revenues were $41.0 million, compared to $6.1 million in the third quarter of 2020. The increase was primarily due to $37.0 million in ORLADEYO net revenue in the third quarter of 2021.
Research and development expenses for the third quarter of 2021 increased to $50.0 million from $30.2 million in the third quarter of 2020, primarily due to increased investment in the development of BCX9930 and other research, preclinical and development costs, offset by a reduction in spend on the ORLADEYO program following our commercial launch in December 2020.
Selling, general and administrative expenses for the third quarter of 2021 increased to $35.0 million, compared to $17.2 million in the third quarter of 2020. The increase was primarily due to increased investment to support the U.S. commercial launch of ORLADEYO and expanded international operations.
Interest expense was $14.1 million in the third quarter of 2021, compared to $2.9 million in the third quarter of 2020. The increase was due to service on the royalty and debt financings, which were completed in December 2020. The interest payment-in-kind (PIK) option on the Athyrium term loan has been exercised and $5.4 million has been added in the third quarter of 2021 and $12.9 million since issuance, to the $125 million principal.
Net loss for the third quarter of 2021 was $58.8 million, or $0.33 per share, compared to a net loss of $46.1 million, or $0.26 per share, for the third quarter of 2020.
Cash, cash equivalents, restricted cash and investments totaled $203.9 million at September 30, 2021, compared to $148.5 million at September 30, 2020. Operating cash use for the third quarter of 2021 was $18.8 million.
Financial Outlook for 2021
Based on the strength of the ORLADEYO launch, and continued growth from new patient demand expected in the fourth quarter, the company now expects full year 2021 net ORLADEYO revenue to be between $115 million and $120 million. Based on our expectations for revenue, operating expenses, and our option to access an additional $75 million from our existing credit facility, we believe our current cash runway takes us into 2023.
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 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 2592545. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 2592545.
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, the European Union, Japan, the United Kingdom and the United Arab Emirates. BioCryst has several ongoing development programs including BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva, and galidesivir, a potential treatment for Marburg virus disease and Yellow Fever. RAPIVAB® (peramivir injection) has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company’s website at www.biocryst.com.
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, including NewBridge Pharmaceuticals and Torii Pharmaceutical Co., Ltd. (“Torii”), 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, which could also impact the amount of any related royalties BioCryst would be entitled to receive from Torii; ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir 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, Health Canada, Swissmedic 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, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.
+1 919 859 7910
Catherine Collier Kyroulis
+1 917 886 5586
|BIOCRYST PHARMACEUTICALS, INC.|
|CONSOLIDATED FINANCIAL SUMMARY|
|(in thousands, except per share)|
|Statements of Operations (Unaudited)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Collaborative and other research and development||1,531||3,370||20,017||8,857|
|Cost of product sales||591||1,517||6,811||1,517|
|Research and development||49,971||30,245||145,279||87,610|
|Selling, general and administrative||34,992||17,195||83,431||46,943|
|Total operating expenses||85,578||48,966||235,555||136,148|
|Loss from operations||(44,584||)||(42,864||)||(125,543||)||(122,352||)|
|Interest and other income||9||(312||)||48||8,892|
|Gain (loss) on foreign currency derivative||(111||)||(12||)||(274||)||31|
|Basic and diluted net loss per common share||$||(0.33||)||$||(0.26||)||$||(0.93||)||$||(0.75||)|
|Weighted average shares outstanding||179,106||176,521||178,199||164,127|
|Balance Sheet Data (in thousands)|
|September 30, 2021||December 31, 2020|
|Cash, cash equivalents and investments||$||199,597||$||300,366|
|Non-recourse notes payable||30,000||30,000|
|Secured term loan||132,050||119,735|
|Royalty financing obligation||142,114||124,717|
|Shares of common stock outstanding||179,791||176,883|
Note 1: Derived from audited financial statements.