Form 8-K
0001629137 False 0001629137 2020-08-05 2020-08-05 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
 

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):  August 5, 2020

_______________________________

Global Blood Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

_______________________________

Delaware 001-37539 27-4825712
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.)

181 Oyster Point Blvd.

South San Francisco, California 94080

(Address of Principal Executive Offices) (Zip Code)

(650) 741-7700

(Registrant's telephone number, including area code)

Not Applicable

(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 class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.001 per share GBT The NASDAQ 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 August 5, 2020, Global Blood Therapeutics, Inc. reported recent business progress and its financial results for the second quarter ended June 30, 2020. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. 

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

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits 

Exhibit No.   Description
     
99.1   Press Release, dated August 5, 2020, furnished herewith
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.

  Global Blood Therapeutics, Inc.
     
   
Date: August 5, 2020 By:  /s/ Jeffrey Farrow        
    Jeffrey Farrow
    Chief Financial Officer
(Principal Financial Officer)
   

 

EdgarFiling

EXHIBIT 99.1

GBT Reports Recent Business Progress and Second Quarter 2020 Financial Results

Achieved Oxbryta® (voxelotor) net revenues of $31.5 million, with approximately 1,000 new patient prescriptions     

Announced plans to seek approval of Oxbryta for younger pediatric patients in the United States and seek approval of Oxbryta in Europe
 

Conference call today at 4:30 p.m. ET

SOUTH SAN FRANCISCO, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today reported recent business progress and financial results for the second quarter ended June 30, 2020.

“In the second quarter of 2020, we continued to make important progress on GBT’s vision of being a leading biopharmaceutical company and the leader in sickle cell disease. Despite the impact of COVID-19, we continued to successfully execute the launch of Oxbryta and make significant progress on new prescriptions, new prescribers, and payer coverage. During the quarter, we were pleased to see increased use of virtual engagements and telemedicine by healthcare professionals and continued growth of Oxbryta prescriptions. In addition, we made significant progress in our efforts to expand the approved use of Oxbryta for more patients in the United States and in Europe, with regulatory submissions planned by mid-2021,” said Ted W. Love, M.D., president and CEO of GBT.

“Last quarter was also marked by a magnification of health disparities driven by COVID-19, which is having an outsized impact on African Americans, and a renewed focus on racial injustice sparked by deaths due to police brutality. The sickle cell disease community lives and breathes these issues, and GBT is working to address them, as evidenced by our cohort of ACCEL grant recipients. We are committed to enacting real and lasting change for communities of color, especially when it comes to ensuring patients have access to the care they need and deserve,” added Dr. Love.

Recent Business Progress

Commercial

Clinical

Corporate

Financial Results for the Second Quarter 2020
Total net product sales for the second quarter of 2020 was $31.5 million, resulting from sales of Oxbryta. The company did not generate product sales in the second quarter of 2019.

Cost of sales for the three months ended June 30, 2020, was $0.4 million. Manufacturing costs incurred prior to FDA approval of Oxbryta in November 2019 were previously recorded as research and development expense in the company’s consolidated statement of operations. GBT expects that the cost of Oxbryta sales as a percentage of revenue will increase in future periods as product manufactured prior to FDA approval, and therefore fully expensed, is utilized. GBT did not incur cost of sales for Oxbryta in the second quarter of 2019 as no product sales were generated.

Research and development (R&D) expenses for the three months ended June 30, 2020, were $34.1 million compared with $36.0 million for the same period in 2019. The decrease in R&D expenses for this comparative period was primarily attributable to a decrease in manufacturing costs for Oxbryta. Following FDA approval of Oxbryta in November 2019, GBT now capitalizes manufacturing of the product to inventory. The decrease in R&D expenses was partially offset by increased costs related to preclinical research and manufacturing activities for inclacumab, increased employee-related costs, and increased costs for other preclinical research activities related to the collaboration with Syros Pharmaceuticals, Inc. Total R&D non-cash stock compensation expense incurred for the three months ended June 30, 2020, was $3.4 million compared with $4.7 million for the same period in 2019.

Sales, general, and administrative (SG&A) expenses for the three months ended June 30, 2020, were $49.1 million compared with $24.8 million for the same period in 2019. The increase in SG&A expenses for this comparative period was primarily attributable to increased employee-related costs, including non-cash stock compensation expense, and increased professional and consulting services associated with the build-out of the company’s commercial operations and launch of Oxbryta. Total SG&A non-cash stock compensation expense incurred in the three months ended June 30, 2020, was $13.1 million compared with $6.2 million for the same period in 2019.

Net loss for the three months ended June 30, 2020, was $52.8 million compared with $57.3 million for the same period in 2019. Basic and diluted net loss per share for the three months ended June 30, 2020, was $0.86 compared with $1.01 for the same period in 2019. The company expects its operating costs to increase in subsequent quarters due to costs associated with expanding commercialization activities as well as costs associated with the advancement of its clinical pipeline.

Cash, cash equivalents, and marketable securities totaled $574.2 million at June 30, 2020, compared with $695.0 million at December 31, 2019.

Conference Call Details
GBT will host a conference call today, Wednesday, August 5, 2020, at 4:30 p.m. ET to provide a general business update and discuss the financial results for the second quarter 2020. To participate in the conference call, please dial 877-407-3982 (domestic) or 201-493-6780 (international). A live audio webcast of the conference call can be accessed on GBT’s website at www.gbt.com under the Investors section. An archived audio webcast will be available for one month following the event.

About Sickle Cell Disease
Sickle cell disease (SCD) affects an estimated 100,000 people in the United States,1 an estimated 52,000 people in Europe,2 and millions of people throughout the world, particularly among those whose ancestors are from sub-Saharan Africa.1 It also affects people of Hispanic, South Asian, Southern European, and Middle Eastern ancestry.1 SCD is a lifelong inherited blood disorder that impacts hemoglobin, a protein carried by red blood cells that delivers oxygen to tissues and organs throughout the body.3 Due to a genetic mutation, people with SCD form abnormal hemoglobin known as sickle hemoglobin. Through a process called hemoglobin polymerization, red blood cells become sickled – deoxygenated, crescent-shaped, and rigid.3-5 The sickling process causes hemolytic anemia (low hemoglobin due to red blood cell destruction) and blockages in capillaries and small blood vessels, which impede the flow of blood and oxygen throughout the body. The diminished oxygen delivery to tissues and organs can lead to life-threatening complications, including stroke and irreversible organ damage.4-7

About Oxbryta® (voxelotor) tablets
Oxbryta (voxelotor) is an oral, once-daily therapy for patients with sickle cell disease (SCD). Oxbryta works by increasing hemoglobin’s affinity for oxygen. Since oxygenated sickle hemoglobin does not polymerize, Oxbryta inhibits sickle hemoglobin polymerization and the resultant sickling and destruction of red blood cells. Through addressing hemolytic anemia and improving oxygen delivery throughout the body, GBT believes that Oxbryta has the potential to modify the course of SCD. On November 25, 2019, Oxbryta received U.S. Food and Drug Administration (FDA) accelerated approval for the treatment of SCD in adults and children 12 years of age and older.8 As a condition of accelerated approval, GBT will continue to study voxelotor in the HOPE-KIDS 2 Study, a post-approval confirmatory study using transcranial Doppler (TCD) flow velocity to assess the ability of Oxbryta to decrease stroke risk in children 2 to 15 years of age.

In recognition of the critical need for new SCD treatments, the FDA granted Oxbryta Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations for the treatment of patients with SCD. The European Medicines Agency (EMA) has included Oxbryta in its Priority Medicines (PRIME) program, and the European Commission (EC) has designated Oxbryta as an orphan medicinal product for the treatment of patients with SCD.

Important Safety Information
Oxbryta should not be taken if the patient has had an allergic reaction to voxelotor or any of the ingredients in Oxbryta. See the end of the patient leaflet for a list of the ingredients in Oxbryta.

Oxbryta can cause serious side effects, including serious allergic reactions. Patients should tell their healthcare provider or get emergency medical help right away if they get rash, hives, shortness of breath, or swelling of the face.

Patients receiving exchange transfusions should talk to their healthcare provider about possible difficulties with the interpretation of certain blood tests when taking Oxbryta.

The most common side effects of Oxbryta include headache, diarrhea, stomach (abdominal) pain, nausea, tiredness, rash, and fever. These are not all the possible side effects of Oxbryta.

Before taking Oxbryta, patients should tell their healthcare provider about all medical conditions, including if they have liver problems; if they are pregnant or plan to become pregnant as it is not known if Oxbryta can harm an unborn baby; or if they are breastfeeding or plan to breastfeed as it is not known if Oxbryta can pass into breastmilk or if it can harm a baby. Patients should not breastfeed during treatment with Oxbryta and for at least 2 weeks after the last dose.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Oxbryta works. Oxbryta may also affect how other medicines work.

Patients are advised to call their doctor for medical advice about side effects. Side effects can be reported to FDA at 1-800-FDA-1088. Side effects can also be reported to Global Blood Therapeutics at 1-833-428-4968 (1-833-GBT-4YOU).

Full Prescribing Information for Oxbryta is available at Oxbryta.com.

About Global Blood Therapeutics
Global Blood Therapeutics (GBT) is a biopharmaceutical company dedicated to the discovery, development, and delivery of life-changing treatments that provide hope to underserved patient communities. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder. The company has introduced Oxbryta® (voxelotor), the first FDA-approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of red blood cell sickling in SCD. GBT is also advancing its pipeline program in SCD with inclacumab, a p-selectin inhibitor in development to address pain crises associated with the disease. In addition, GBT’s drug discovery teams are working on new targets to develop the next generation of treatments for SCD. To learn more, please visit www.gbt.com and follow the company on Twitter @GBT_news.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, including statements containing the words “will,” “anticipates,” “plans,” “believes,” “forecast,” “estimates,” “expects,” and “intends,” or similar expressions. These forward-looking statements are based on GBT’s current expectations and actual results could differ materially. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. GBT intends these forward-looking statements, including statements regarding GBT’s priorities, commitment, dedication, focus, goals, and vision; the safety, efficacy, and mechanism of action of Oxbryta, and other product characteristics; the commercialization, delivery, availability, and commercial and medical potential of Oxbryta; use of Oxbryta, including new prescriptions and related expectations; payer coverage for Oxbryta; ongoing and planned studies of Oxbryta and related protocols, activities, and expectations, including with respect to resumption of enrollment and participation in clinical trials and the impact on related timelines; GBT’s financial position, outlook, guidance, and expectations; the COVID-19 pandemic and related expectations; the potential expansion of the approved use of Oxbryta for more patients in the U.S. and potential approval of Oxbryta to treat patients in Europe, including the submission of regulatory filings, the type and contents of such filings, and related timing; impacting the treatment, care and course of SCD; GBT’s efforts with respect to health disparities, racial injustice, and enacting change; the significance and potential impact of the ACCEL program and the grant recipients; the potential of inclacumab; and advancing GBT’s pipeline, working on new targets, and discovering, developing, and delivering treatments, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and GBT makes this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect GBT’s current views about its plans, intentions, expectations, strategies, and prospects, which are based on the information currently available to the company and on assumptions the company has made. GBT can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved, and, furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond GBT’s control including, without limitation, risks and uncertainties relating to the COVID-19 pandemic, including the extent and duration of the impact on GBT’s business, including commercialization activities, regulatory efforts, research and development, corporate development activities, and operating results, which will depend on future developments that are highly uncertain and cannot be accurately predicted, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing, and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease; the risks that GBT has only recently established its commercialization capabilities and may not be able to successfully commercialize Oxbryta; risks associated with GBT’s dependence on third parties for development, manufacture, and commercialization activities related to Oxbryta; government and third-party payor actions, including those relating to reimbursement and pricing; risks and uncertainties relating to competitive products and other changes that may limit demand for Oxbryta; the risks regulatory authorities may require additional studies or data to support continued commercialization of Oxbryta; the risks that drug-related adverse events may be observed during commercialization or clinical development; data and results may not meet regulatory requirements or otherwise be sufficient for further development, regulatory review, or approval; compliance with the funding and other obligations under the Pharmakon loan; and the timing and progress of GBT’s and Syros’ research and development activities under their collaboration; along with those risks set forth in GBT’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and in GBT’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in GBT’s subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, GBT assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.

References

  1. Centers for Disease Control and Prevention website. Sickle Cell Disease (SCD). https://www.cdc.gov/ncbddd/sicklecell/data.html. Accessed June 3, 2019.
  2. European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3182125. Accessed June 12, 2020.
  3. National Heart, Lung, and Blood Institute website. Sickle Cell Disease. https://www.nhlbi.nih.gov/health-topics/sickle-cell-disease. Accessed August 5, 2019.
  4. Rees DC, et al. Lancet. 2010;376(9757):2018-2031.
  5. Kato GJ, et al. Nat Rev Dis Primers. 2018;4:18010.
  6. Kato GJ, et al. J Clin Invest. 2017;127(3):750-760. 
  7. Caboot JB, et al. Paediatr Respir Rev. 2014;15(1):17-23.
  8. Oxbryta (voxelotor) tablets prescribing information. South San Francisco, Calif. Global Blood Therapeutics, Inc.; November 2019.


GLOBAL BLOOD THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
 (In thousands, except share and per share amounts)

  Three Months Ended June 30,   Six Months Ended June 30, 
    2020      2019      2020      2019  
  (Unaudited) (Unaudited) (Unaudited) (Unaudited)
Product sales, net $ 31,501   $   $ 45,619   $  
Costs and operating expenses:        
Cost of sales   377         512      
Research and development   34,085     36,010     73,858     70,476  
Selling, general and administrative   49,075     24,794     96,736     42,849  
Total costs and operating expenses   83,537     60,804     171,106     113,325  
Loss from operations   (52,036 )   (60,804 )   (125,487 )   (113,325 )
Other income (expense):        
Interest income   1,514     3,706     4,370     7,537  
Interest expense   (2,282 )   (160 )   (4,596 )   (341 )
Other expenses, net   (36 )   (63 )   (153 )   (115 )
Total other income, net   (804 )   3,483     (379 )   7,081  
Net loss $ (52,840 ) $ (57,321 ) $ (125,866 ) $ (106,244 )
Basic and diluted net loss per common share $ (0.86 ) $ (1.01 ) $ (2.06 ) $ (1.88 )
Weighted-average number of shares used in computing
  basic and diluted net loss per common share
  61,116,707     56,539,760     60,952,269     56,386,560  
         


GLOBAL BLOOD THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands)

  June 30, 2020   December 31, 2019
Assets (Unaudited)    
Current assets:      
Cash and cash equivalents $ 384,716     $ 302,237  
Short-term marketable securities   156,014       307,732  
Other current assets   53,303       18,028  
Total current assets   594,033       627,997  
Property and equipment, net   39,668       27,113  
Long-term marketable securities   33,479       85,030  
Operating lease right-of-use assets   51,580       52,775  
Other assets   2,907       3,184  
Total assets $ 721,667
    $ 796,099  
Liabilities and Stockholders’ Equity      
Current liabilities $   69,402     $   71,453  
Long-term debt   73,775       73,559  
Operating lease liabilities, noncurrent   81,903       72,359  
Other noncurrent liabilities   771       34  
Total liabilities   225,851       217,405  
Total stockholders’ equity   495,816       578,694  
Total liabilities and stockholders’ equity $ 721,667     $ 796,099  

Contact Information:
Steven Immergut (media)
650-410-3258
simmergut@gbt.com

Stephanie Yao (investors)
650-741-7730
syao@gbt.com