8-K
false 0001571498 0001571498 2020-08-04 2020-08-04

 

 

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 4, 2020

 

 

EPIZYME, INC.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   001-35945   26-1349956

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

400 Technology Square,

Cambridge, Massachusetts

  02139
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 229-5872

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

 

Name of each exchange

on which registered

Common stock, $0.0001 par value   EPZM   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 4, 2020, Epizyme, Inc., a Delaware corporation (the “Company”) announced its financial results for the 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 and is incorporated herein by reference.

The information provided under 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 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01

Financial Statements and Exhibits

(d) Exhibits

 

99.1    Press release issued by the Company on August 4, 2020*
104    Cover Page Interactive Date File (embedded within Inline XBRL document)

 

*

The exhibit shall be deemed to be furnished, and not filed.


SIGNATURES

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.

 

    EPIZYME, INC.
Date: August 4, 2020     By:  

/s/ Robert B. Bazemore

      Robert B. Bazemore
      President and Chief Executive Officer
EX-99.1

Exhibit 99.1

 

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Epizyme Reports Business Progress and Second Quarter 2020 Financial Results

TAZVERIK® Approved for Multiple Cancer Indications; Executing Well on Commercial Launches for TAZVERIK in Epithelioid Sarcoma and Follicular Lymphoma

Conference Call to be Held Today, August 4 at 8:30 a.m. ET

CAMBRIDGE, Mass., Aug. 4, 2020Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today provided business and portfolio updates and reported second quarter 2020 financial results.

“With back-to-back FDA approvals for TAZVERIK over the course of the last six months, we have a significant opportunity to provide a safe and effective new therapeutic option to patients in need,” said Robert Bazemore, president and chief executive officer of Epizyme. “As we move into the second half of the year, we are focused on the successful execution of our launches and all other aspects of our business. Despite the evolving COVID-19 situation, our commercial launches are proceeding very well, and our in-house and clinical collaboration efforts to evaluate tazemetostat in additional combinations and indications remain on track. We have delivered on the major corporate objectives we set for the first half of 2020, and we look forward to the continued advancement of our programs in order to help as many patients as possible.”

Recent Progress

 

   

TAZVERIK Approval and Commercial Launch Underway in Relapsed or Refractory Follicular Lymphoma (FL): TAZVERIK was granted accelerated approval and became commercially available to eligible patients on June 18, 2020. Epizyme’s field team began engaging immediately with the FL prescribing community, with the first prescription filled on June 25, 2020, and initial feedback from physicians and payors on this approval and the TAZVERIK label has been highly positive.

 

   

TAZVERIK Added to NCCN Clinical Practice Guidelines for FL: Shortly after the FDA approval of TAZVERIK in FL, the National Comprehensive Cancer Network updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for FL to include TAZVERIK as a recommended category 2A treatment for patients with relapsed or refractory FL. The NCCN Guidelines are the recognized clinical standard for cancer care by U.S. healthcare providers and payers and are maintained by a committee of expert physicians from leading U.S. cancer centers.

 

   

Continued Commercial Execution for TAZVERIK in Epithelioid Sarcoma (ES): TAZVERIK became commercially available to patients on February 1, 2020, following its accelerated approval on January 23, 2020, for the treatment of metastatic or locally advanced ES. Amidst the COVID-19 situation, the field-based teams are executing well and leveraging virtual and other non-personal methods to continue to engage with customers. At the end of the second quarter, TAZVERIK had generated total net product sales of $3.5 million since its launch, primarily comprised of sales in ES.


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Expansion Development of Tazemetostat Remains on-Track: Epizyme’s expansion program to further investigate tazemetostat’s therapeutic potential in earlier lines of therapy for FL, including several combination regimens with anti-cancer therapies, as well as in other cancer indications and combinations, is advancing as planned and remains on track.

Financial Guidance

Based on its current operating plans, Epizyme continues to believe that its existing cash, cash equivalents and marketable securities will fund the company’s operations into at least 2022. The company expects its non-GAAP adjusted cash-based operating expenses for 2020 will be between $235 and $255 million, which excludes any milestone payments paid by the company and non-cash items, such as stock-based compensation and amortization or depreciation of intangibles.

Second Quarter 2020 Financial Results

 

   

Cash Position: Cash, cash equivalents and marketable securities were $322.1 million as of June 30, 2020, as compared to $376.5 million as of March 31, 2020.

 

   

Revenue: Total revenue for the second quarter of 2020 was $2.5 million, comprised of $2.2 million in net sales of TAZVERIK in the U.S. and $0.2 million in collaboration revenue, compared to $1.4 million in Q1 2020, comprised of $1.3 million in net sales of TAZVERIK in the U.S. following its launch in January 2020 and $0.1 million in collaboration revenue.

 

   

Operating Expenses: Total GAAP operating expenses were $60.0 million for the second quarter of 2020, compared to $52.7 million for the first quarter of 2020. Total non-GAAP adjusted operating expenses were $50.9 million for the second quarter of 2020, compared to $45.7 million for the first quarter of 2020.

 

   

R&D expenses: GAAP R&D expenses were $26.4 million for the second quarter of 2020, compared to $25.2 million for the first quarter of 2020, while non-GAAP adjusted R&D expenses were $23.4 million for the second quarter of 2020, compared to $22.9 million for the first quarter of 2020. The increase was primarily due to expenses related to the support of our clinical trials and development candidates.

 

   

SG&A expenses: GAAP SG&A expenses were $32.7 million for the second quarter of 2020, compared to $ 26.9 million for the first quarter of 2020, while non-GAAP adjusted SG&A expenses were $27.1 million for the second quarter of 2020, compared to $22.5 million for the first quarter of 2020. The increase was primarily due to expenses related to the company’s expansion of its infrastructure to support the launch in FL.

 

   

Eisai Milestone Payments: Following the approval of TAZVERIK in the FL indication, the final milestone owed to Eisai of $25 million under the collaboration agreement was paid and funded by the third and final tranche of the $70 million loan facility with Pharmakon Advisors.


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Net Loss (GAAP): Net loss attributable to common stockholders was $58.5 million, or $0.58 per share, for the second quarter of 2020, compared to $50.9 million, or $0.51 per share, for the first quarter of 2020.

A reconciliation of cash-based financial measures directly comparable to GAAP financial measures is presented in the table attached to this press release.

Conference Call Information

Epizyme will host a conference call today, August 4, at 8:30 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 5081295. A webcast will be available in the investor section of the company’s website at www.epizyme.com, and will be archived for 60 days following the call.

About Non-GAAP Financial Measures

In addition to financial information prepared in accordance with the U.S. generally accepted accounting principles (GAAP), this press release includes the following non-GAAP financial measures: total non-GAAP adjusted operating expenses on a historical and projected basis, non-GAAP R&D expenses on a historical basis and non-GAAP SG&A expenses on a historical basis. Epizyme derives these non-GAAP financial measures by excluding certain expenses and other items from the respective GAAP financial measure, that is most directly comparable to each non-GAAP financial measure. Specifically, the non-GAAP financial measures exclude stock-based compensation expense, amortization or depreciation of intangibles and milestone payments related to TAZVERIK that are payable under the company’s collaboration agreement with Eisai Pharmaceuticals. The company’s management believes that these non-GAAP financial measures are useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to total operating expenses is not available without unreasonable effort primarily due to the company’s inability to predict with reasonable certainty the amount of future stock-based compensation expense.

About TAZVERIK

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

 

   

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

 

   

Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.

 

   

Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.


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These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The most common (³20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (³20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: Epizyme.com

About Epizyme, Inc.

Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the successful launch of commercial sales of TAZVERIK for epithelioid sarcoma and follicular lymphoma in the approved indications; whether tazemetostat will receive marketing approval for epithelioid sarcoma or follicular lymphoma in other jurisdictions, full approval in the United States or approval in any other indication; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials, such as the ongoing confirmatory trials; whether results from clinical studies will warrant meetings with regulatory authorities, submissions for regulatory approval or review by governmental authorities under the accelerated approval process; expectations for regulatory approvals, including accelerated approval, to conduct trials or to market products; the impact of the COVID-19 pandemic on the company’s business, results of operations and financial


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condition; whether the company’s cash resources will be sufficient to fund the company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial success of tazemetostat or the company’s therapeutic candidates; and other factors discussed in the “Risk Factors” section of the company’s most recent Form 10-Q filed with the SEC and in the company’s other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.

TAZVERIK® is a registered trademark of Epizyme, Inc.

Contacts

Media:

Erin Graves, Epizyme, Inc.

Media@epizyme.com

(617) 500-0615

Investors:

Alicia Davis, THRUST Strategic Communications

alicia@thrustsc.com

(910) 620-3302


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EPIZYME, INC

CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)

(Amounts in thousands)

 

     June 30,
2020
     December 31,
2019
 
Consolidated Balance Sheet Data:              

Cash and cash equivalents

   $  117,152      $  139,482  

Marketable securities

     204,910        241,605  

Intangible assets, net

     49,079        —    

Total assets

     427,383        424,589  

Total current liabilities

     30,655        34,386  

Deferred revenue

     3,933        3,806  

Long-term debt, net of debt discount

     68,464        23,309  

Liability related to sale of future royalties

     13,388        12,793  

Total stockholders’ equity

     293,363        331,137  

EPIZYME, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

(Amounts in thousands except per share data)

 

     Three Months Ended     Six Months Ended     Three
Months
Ended
 
     June 30     June 30     March 31  
     2020     2019     2020     2019     2020  

Revenues

          

Product revenue, net

   $ 2,234     $ —       $ 3,519     $ —       $ 1,284  

Collaboration revenue

     233       5,900       303       13,791       70  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     2,467       5,900       3,822       13,791       1,354  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses

          

Cost of product revenue

     1,022       —         1,637       —         614  

Research and development

     26,352       40,907       51,516       67,803       25,163  

Selling, general and administrative

     32,659       15,698       59,584       27,684       26,927  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     60,033       56,605       112,737       95,487       52,704  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (57,566     (50,705     (108,915     (81,696     (51,350

Other income, net:

          

Interest (expense) income, net

     (569     2,253       187       3,911       756  

Other expense, net

     (15     (13     (64     (19     (48

Non-cash interest expense related to sale of future royalties

     (301     —         (596     —         (295
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other (expense) income, net:

     (885     2,240       (473     3,892       413  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (58,451     (48,465     (109,388     (77,804     (50,937

Income provision

     —         —         —         —         —    
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $  (58,451   $  (48,465   $  (109,388   $  (77,804   $  (50,937
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Reconciliation of net loss to net loss attributable to common stockholders

          

Net loss

   $  (58,451   $  48,465   $  (109,388   $ (77,804   $  (50,937

Accretion of convertible preferred stock

     —         —         —         (2,940     —    
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders

   $  (58,451   $ (48,465   $  (109,388   $ (80,744   $  (50,937
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to common stockholders - basic and diluted

   $ (0.58   $ (0.53   $ (1.09   $ (1.04   $ (0.51

Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted

     101,104       90,876       100,360       77,315       99,616  


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EPIZYME, INC.

Reconciliation of Selected GAAP Measures to Non-GAAP Measures (UNAUDITED)

(Amounts in thousands)

 

     Three Months Ended     Six Months Ended     Three
Months
Ended
 
     June 30     June 30     March 31  

Reconciliation of GAAP to Non-GAAP Cost of Product Revenue

     2020       2019       2020       2019       2020  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

GAAP Cost of Product Revenue

   $ 1,022     $ —       $ 1,637     $ —       $ 614  

Less: Depreciation and Amortization

     (623     —         (921     —         (298
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Cost of Product Revenue

   $ 399     $ —       $ 716     $ —       $ 316  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Reconciliation of GAAP to Non-GAAP Research and Development

          

GAAP Research and Development

   $  26,352     $ 40,907     $ 51,516     $ 67,803     $  25,163  

Less: Stock-Based Compensation Expenses

     (2,803     (1,732     (4,966     (2,897     (2,162

Less: Depreciation and Amortization

     (130     (157     (268     (315     (138

Less: Eisai R&D Milestone Expense

     —         (10,000     —         (10,000     —    
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Research and Development

   $ 23,419     $ 29,018     $ 46,282     $ 54,591     $ 22,863  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Reconciliation of GAAP to Non-GAAP Selling, General and Administrative:

          

GAAP Selling, General and Administrative

   $ 32,659     $ 15,698     $ 59,584     $ 27,684     $ 26,927  

Less: Stock-Based Compensation Expenses

     (5,488     (2,996     (9,836     (5,042     (4,348

Less: Depreciation and Amortization

     (100     (52     (193     (101     (93
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Selling, General and Administrative

   $ 27,071     $ 12,650     $ 49,555     $ 22,541     $ 22,486  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Reconciliation of GAAP to Non-GAAP Operating Expenses

          

GAAP Operating Expenses

   $ 60,033     $ 56,605     $  112,737     $ 95,487     $ 52,704  

Less: Stock-Based Compensation Expenses

     (8,291     (4,728     (14,802     (7,939     (6,510

Less: Depreciation and Amortization

     (853     (209     (1,382     (416     (529

Less: Eisai R&D Milestone Expense

     —         (10,000     —         (10,000     —    
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Operating Expenses

   $ 50,889     $ 41,668     $ 96,553     $ 77,132     $ 45,665