On August 4, 2020 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported second quarter 2020 financial results (Press release, Epizyme, AUG 4, 2020, View Source [SID1234562815]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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.
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.
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.
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