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): May 6, 2020  

BioCryst Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)

Delaware000-2318662-1413174
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)

 

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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 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 May 6, 2020, BioCryst Pharmaceuticals, Inc. (the “Company”) issued a news release announcing recent corporate developments and its financial results for the quarter ended March 31, 2020, which also referenced a conference call and webcast to discuss these recent corporate developments and financial results. A copy of the news 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 furnished is not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, is not subject to the liabilities of that section and is not deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description
   
99.1 Press release dated May 6, 2020 entitled “BioCryst Reports First Quarter 2020 Financial Results and Upcoming Key Milestones”

 


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: May 6, 2020By: /s/ Alane Barnes        
  Alane Barnes
  Senior Vice President and Chief Legal Officer
  

EdgarFiling

EXHIBIT 99.1

BioCryst Reports First Quarter 2020 Financial Results and Upcoming Key Milestones

—Berotralstat approval/launch timelines in U.S., Japan, EU remain on track—

—Early clinical data supports BCX9930 as oral monotherapy for complement-mediated diseases—

—Patient dosing underway in galidesivir trial in COVID-19 patients in Brazil—

RESEARCH TRIANGLE PARK, N.C., May 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced financial results for the first quarter ended March 31, 2020, and provided a corporate update.

“This is a transformational year for BioCryst as we prepare to launch berotralstat in multiple territories to bring our oral, once-daily prophylactic medicine to HAE patients, and begin generating significant revenue,” said Jon Stonehouse, president and chief executive officer of BioCryst.

“We are excited to see the clinical response in treatment-naïve PNH patents at the 50 mg and 100 mg twice-daily dose levels, and more than 98 percent suppression of complement in both alternative pathway assays at the 200 mg and 400 mg twice-daily levels in healthy volunteers,” said Dr. William Sheridan, chief medical officer of BioCryst. 

“This profile provides strong support for BCX9930 as an oral monotherapy. We look forward to studying 200 mg and 400 mg twice-daily in PNH patients and advancing this program to treat multiple complement-mediated diseases,” Sheridan added.

Program Updates and Key Milestones

Hereditary Angioedema (HAE) Program – Berotralstat (BCX7353): Oral, once-daily treatment for prevention of HAE attacks

Complement Oral Factor D Inhibitor Program – BCX9930

Given these data, the company expects to achieve its goal of monotherapy for PNH patients in cohort 2 (200 mg and 400 mg twice-daily).
             
Additional details can be found on slides, which can be accessed at the Investors’ section of BioCryst’s website at http://www.biocryst.com.

Coronavirus Antiviral Program – Galidesivir (BCX4430)

Additional Updates

First Quarter 2020 Financial Results

For the three months ended March 31, 2020, total revenues were $4.8 million, compared to $5.9 million in the first quarter of 2019. The decrease was primarily due to reduced peramivir product sales and lower royalty revenues, partially offset by amortization of deferred revenue from the Torii Pharmaceutical, Co. commercialization agreement.

Research and development (R&D) expenses for the first quarter of 2020 increased to $29.9 million from $27.5 million in the first quarter of 2019, primarily due to due to increased spending on the company’s complement-mediated diseases program and other preclinical development initiatives.

Selling, general and administrative (SG&A) expenses for the first quarter of 2020 increased to $15.9 million, compared to $6.2 million in the first quarter of 2019. The increase was primarily due to increased spending on commercial activities and medical affairs to support the U.S. commercial launch of berotralstat in 2020 and contingent legal costs associated with our Seqirus UK Limited (Seqirus) dispute.

Interest and other income were $6.4 million in the first quarter of 2020, compared to $0.6 million in the first quarter of 2019. The increase was primarily due to the partial arbitration award related to our Seqirus dispute.

Interest expense was $3.0 million in the first quarter of 2020, compared to $2.7 million in the first quarter of 2019 and was associated with an increase in the outstanding balance of the company’s secured credit facility in February 2019 and increased interest expense associated with the company’s non-recourse notes payable.

Net loss for the first quarter of 2020 was $37.6 million, or $0.24 per share, compared to a net loss of $31.1 million, or $0.28 per share, for the first quarter of 2019. 

Cash, cash equivalents and investments totaled $114.6 million at March 31, 2020, and reflect a decrease from $137.8 million at December 31, 2019. Operating cash use for the first quarter of 2020 was $23.1 million.

Financial Outlook for 2020

BioCryst expects full year 2020 net operating cash use to be in the range of $125 to $150 million, and its operating expenses to be in the range of $135 to $160 million. The company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the company’s stock, as well as by the vesting of the company’s outstanding performance-based stock options.

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 # 4679821. 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 # 4679821.

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. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are 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, performances 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: that the ongoing COVID-19 pandemic could create challenges in all aspects of our business, including without limitation delays, stoppages, difficulties and increased expenses with respect to our and our partners’ development, regulatory processes and supply chains, could negatively impact our ability to access the capital or credit markets to finance our operations, or could have the effect of heightening many of the risks described below or in the documents we file periodically with the Securities and Exchange Commission; that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that BioCryst may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, or may not provide regulatory clearances which may result in delay of planned clinical trials, or may impose a clinical hold with respect to such product candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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.

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,
  2020   2019 
Revenues:    
Product sales$218  $1,679 
Royalty revenue 1,945   2,322 
Collaborative and other research and development 2,660   1,886 
Total revenues 4,823   5,887 
     
Expenses:  
Cost of product sales -   1,399 
Research and development 29,867   27,493 
Selling, general and administrative 15,865   6,238 
Royalty 69   87 
Total operating expenses 45,801   35,217 
     
Loss from operations (40,978)  (29,330)
     
Interest and other income 6,446   596 
Interest expense (3,047)  (2,726)
(Loss) gain on foreign currency derivative (20)  406 
     
Net loss$(37,599) $(31,054)
     
Basic and diluted net loss per common share$(0.24) $(0.28)
     
Weighted average shares outstanding 154,156   110,167 
     


      
Balance Sheet Data (in thousands)     
 March 31, 2020 December 31, 2019
 (Unaudited) (Note 1)
Cash, cash equivalents and investments$113,058  $136,226 
Restricted cash 1,559   1,551 
Receivables from collaborations 5,642   22,146 
Total assets 136,589   175,282 
Non-recourse notes payable 29,671   29,561 
Senior credit facility 50,539   50,309 
Accumulated deficit (878,227)  (840,628)
Stockholders’ equity 3,648   38,252 
Shares of common stock outstanding 154,192   154,082 
       

Note 1: Derived from audited financial statements.