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Kezar Life Sciences Reports First Quarter Financial Results and Provides Business Updates

• KZR-616 clinical development in three severe autoimmune diseases is advancing with several data readouts expected in 2021 and 2022
• KZR-261 IND submission expected mid-2021, with Phase 1 trial in solid tumors expected to initiate before year-end
• Cash, cash equivalents and marketable securities of $142 million as of March 31, 2021

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced its first quarter 2021 financial results and corporate highlights.

“Last quarter saw excellent execution by the Kezar team across both of our programs. We look forward to sharing data this June from the completed Phase 1b portion of the MISSION study of KZR-616 in SLE patients, followed by an interim review of the Phase 2 portion of MISSION in LN patients in the fourth quarter. Our conviction continues to deepen that immunoproteasome inhibition has the potential to be a powerful, differentiated treatment approach for patients with autoimmune diseases,” said John Fowler, Kezar’s Co-founder and Chief Executive Officer. “In addition, we are on track to submit an IND for KZR-261, our first-in-class protein secretion inhibitor, in mid-2021 and commence a Phase 1 study in solid tumors shortly thereafter.”

Clinical Highlights & Updates

KZR-616: Selective Immunoproteasome Inhibitor

MISSION – Phase 1b/2 clinical trial in patients with systemic lupus erythematous (SLE) and lupus nephritis (LN), respectively (NCT03393013)

• The last patient from the MISSION Phase 1b completed treatment in February 2021, and final clinical data from this 25-week safety and tolerability study of up to 75 mg weekly of KZR-616 in 47 patients with SLE will be presented during the European Congress of Rheumatology (EULAR 2021) in June.
• The amended Phase 2 open-label portion of the MISSION trial in patients with active, proliferative lupus nephritis opened for enrollment in August 2020 and is actively recruiting. The primary efficacy endpoint for the trial is the proportion of patients achieving a renal response measured by a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at six months.
  • Interim data are expected in late 2021, and topline data are expected in the first half of 2022.

PRESIDIO – Phase 2 clinical trial in patients with dermatomyositis (DM) and polymyositis (PM) (NCT04033926)

• The PRESIDIO Phase 2, placebo controlled cross-over trial of KZR-616 in DM and PM is actively enrolling. Additionally, a 12-month open-label extension study is open to patients completing the 32-week placebo-controlled trial (NCT04628936).
  • Topline data are expected in the first half of 2022.

Protein Secretion Program

• KZR-261 is a first-in-class protein secretion inhibitor which targets the Sec61 translocon and has demonstrated broad anti-tumor activity in preclinical models of both solid and hematologic malignancies.
  • Pending successful completion of drug product manufacturing, submission of an Investigational New Drug (IND) application for KZR-261 is anticipated in mid-2021. The Phase 1 clinical trial will evaluate pharmacokinetics, safety, and tolerability in patients with solid tumors as well as preliminary signs of efficacy in tumor-specific expansion cohorts. The trial is expected to commence shortly after the IND becomes effective.
  • Two abstracts featuring Kezar’s small molecule inhibitors of the Sec61 translocon were presented in April during the American Association of Cancer Research (AACR) 2021 Virtual Annual Meeting.

Corporate Update

• In May 2021, Kezar was recognized as a winner of the 2021 Bay Area Best Places to Work, an awards program presented by the San Francisco Business Times and the Silicon Valley Business Journal.

Financial Results

• Cash, cash equivalents and marketable securities totaled $142.3 million as of March 31, 2021, compared to $140.4 million as of December 31, 2020. The increase in cash, cash equivalents and marketable securities was primarily attributable to the net proceeds from the issuance of common stock under the “at-the-market” Sales Agreement with Cowen and Company, LLC, offset by cash used by the company in operations to advance its clinical-stage programs and preclinical research and development.
• Research and development expenses for the first quarter of 2021 increased by $1.8 million to $9.3 million compared to $7.5 million in the first quarter of 2020. This increase was primarily related to advancing the KZR-616 clinical program in multiple indications and the protein secretion preclinical program.
• General and administrative expenses for the first quarter of 2021 increased by $0.8 million to $3.8 million compared to $3.0 million in the first quarter of 2020. The increase was primarily due to an increase in personnel expenses and stock-based compensation as a result of an increase in headcount and salaries and an increase in the cost of directors’ and officers’ liability insurance.
• Net loss for the first quarter of 2021 was $13.0 million, or $0.25 per basic and diluted common share, compared to a net loss of $10.0 million, or $0.30 per basic and diluted common share, for the first quarter of 2020.
• Total shares of common stock outstanding were 48.1 million shares as of March 31, 2021. Additionally, there were outstanding pre-funded warrants to purchase 3.8 million shares of common stock at an exercise price of $0.001 per share and outstanding options to purchase 7.1 million shares of common stock at a weighted-average exercise price of $5.90 per share as of March 31, 2021.

About KZR-616

KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b clinical trials provide evidence that KZR-616 exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. Phase 2 trials are underway in severe autoimmune diseases.

About KZR-261

KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar’s research and discovery efforts targeting protein secretion pathway. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered by Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company’s proprietary platform evaluating Sec61 modulation. As a result, Kezar has established a broad library of protein secretion inhibitors. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent for the treatment of solid and hematologic malignancies. An IND submission in solid tumors is expected to be filed in mid-2021.

About Lupus Nephritis

Lupus nephritis is one of the most serious complications of systemic lupus erythematosus. LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.

About Dermatomyositis and Polymyositis

Dermatomyositis and Polymyositis are two of the five types of autoimmune myositis diseases. Both are chronic, debilitating, inflammatory autoimmune myopathies that are distinguished by inflammation of the muscles as well as the skin (in DM). Approximately 30,000 to 120,000 people in the United States are living with these severe and progressive inflammatory myopathies that are characterized by marked morbidity and associated mortality. While debilitating muscle weakness is the hallmark of these myopathies, including compromised muscles of respiration, other internal organ system dysfunctions can be equally disabling. The aim of treatment for these diseases is to suppress inflammation, increase muscle strength and prevent long-term damage to muscles and extramuscular organs; however, treatment options are limited for DM, and there are currently no approved treatments for PM.

About Kezar Life Sciences

Kezar Life Sciences is a clinical-stage biopharmaceutical company bringing novel treatments to patients with rare autoimmune diseases and cancer. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function to inhibit multiple drivers of disease via single, powerful targets. KZR-616, its lead development candidate, is a selective immunoproteasome inhibitor being evaluated in Phase 2 clinical trials in lupus nephritis, dermatomyositis and polymyositis. Additionally, KZR-261, the first anti-cancer clinical candidate from the company’s platform targeting the Sec61 translocon and the protein secretion pathway, is undergoing IND-enabling activities. For more information, visit www.kezarlifesciences.com.

Cautionary Note on Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “should,” “expect,” “believe” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the design, progress, timing, scope and results of clinical trials, the anticipated timing of disclosure of results of clinical trials, plans for initiating future clinical trials, the likelihood data will support future development, the association of data with treatment outcomes, the likelihood of obtaining regulatory approval of Kezar’s product candidates and the timing of regulatory filings. Many factors may cause differences between current expectations and actual results, including the impacts of the COVID-19 pandemic, unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

KEZAR LIFE SCIENCES, INC.
Selected Balance Sheets Data
(In thousands)
		March 31, 2021			December 31, 2020
		(unaudited)
Cash, cash equivalents and marketable securities		$	142,308		$	140,447
Total assets			152,337			151,842
Total current liabilities			7,561			6,442
Total stockholders’ equity			140,637			140,978

Summary of Operations Data
(Unaudited in thousands except share and per share data)
		Three Months Ended
		March 31,
		2021		2020
Operating expenses:
Research and development		$9,286		$7,457
General and administrative		3,762		3,021
Total operating expenses		13,048		10,478
Loss from operations		(13,048)		(10,478)
Interest income		54		466
Net loss		($12,994)		($10,012)
Net loss per common share, basic and diluted		($0.25)		($0.30)
Weighted-average shares used to compute net loss per common share, basic and diluted		51,058,039		32,867,597

 

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Celia Economides

SVP, Strategy & External Affairs

[email protected]

Argot Partners

(212)-600-1902

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

Posted on May 12, 2021 4:04 pm

Energous Corporation Reports First Quarter 2021 Financial Results

Energous Corporation Reports First Quarter 2021 Financial Results

SAN JOSE, Calif.–(BUSINESS WIRE)–
Energous Corporation (NASDAQ: WATT), the developer of WattUp®, a revolutionary Wireless Charging 2.0 technology, today announced financial results for the first quarter ended March 31, 2021 and provided an update on its operational progress.

Recent Highlights

• Energous achieved European regulatory approval for its WattUp PowerHub with unlimited distance restrictions
• Energous partnered with e-peas to advance at-a-distance wireless charging applications greater than one meter
• Energous partnered with Thinfilm to enable ultrathin, reliable, wirelessly rechargeable devices

“The recent European approval indicates we are making distinct progress toward expanding the number of applications for our WattUp at-a-distance charging technology,” said Brian Sereda, senior vice president and chief financial officer of Energous Corporation. “As our technology continues to make progress toward general commercial availability, we are seeing growing interest in RF charging from consumer, IoT, medical and industrial device manufacturers.”

Unaudited 2021 First Quarter Financial Results

For the first quarter ended Mar. 31, 2021, Energous recorded:

• Revenue of $145,065
• Operating expenses of approximately $8.7 million (GAAP), comprised of $4.6 million in research and development, and $4.1 million in selling, general and administrative expenses
• Net loss of $8.5 million, or $0.14 per basic and diluted share
• Adjusted EBITDA (a non-GAAP financial measure) loss of $6.3 million
• $44.8 million in cash and cash equivalents at the end of the first quarter, with no debt

2021 First Quarter Conference Call

Energous will host a conference call to discuss its financial results, recent progress and prospects for the future.

When: Wednesday, May 12, 2021

Time: 1:30 p.m. PT (4:30 p.m. ET)

Phone: 888-317-6003 (domestic); +1 412-317-6061 (international)

Passcode: 2181664

Telephonic replay: Accessible through May 19, 2021

877-344-7529 (domestic); 412-317-0088 (international); passcode 10155746

Webcast: Accessible at Energous.com; archive available for approximately one year

About Energous Corporation

Energous Corporation (Nasdaq: WATT) is the global leader of Wireless Charging 2.0 technology. Its award-winning WattUp® solution is the only technology that supports both contact and distance charging through a fully compatible ecosystem. Built atop fast, efficient, and highly scalable RF-based charging technology, WattUp is positioned to offer improvements over older, first generation coil-based charging technologies in power, efficiency, foreign device detection, freedom of movement and overall cost for consumer electronics, medical devices, retail, military, industrial/commercial IoT, automotive, military, retail and industrial applications. Energous develops silicon-based wireless power transfer (WPT) technologies and customizable reference designs, and provides worldwide regulatory assistance, a reliable supply chain, quality assurance, and sales and technical support to global customers. The company received the world’s first FCC Part 18 certification for at-a-distance wireless charging and has been awarded 236 U.S. patents for its WattUp wireless charging technology to-date.

Safe Harbor Statement

This press release contains “forward-looking statements” within the meaning of the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact included in this press release are forward-looking statements. Forward-looking statements may describe our future plans and expectations and are based on the current beliefs, expectations and assumptions of Energous. These statements generally use terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or similar terms. Examples of our forward-looking statements in this release include but are not limited to our statements about Energous’ financial results, the future of the global wireless charging industry, our technology or statements about any governmental approvals we may need to operate our business, and statements with respect to its expected functionality and company growth. Factors that could cause actual results to differ from what we expect include: uncertain timing of necessary regulatory approvals; timing of customer product development and market success of customer products; our dependence on distribution partners; and intense industry competition. We urge you to consider those factors, and the other risks and uncertainties described in our most recent annual report on Form 10-K as filed with the Securities and Exchange Commission (SEC), any subsequent quarterly reports on Form 10-Q as well as in other documents that may be subsequently filed by Energous, from time to time, with the SEC, in evaluating our forward-looking statements. In addition, any forward-looking statements represent Energous’ views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Energous does not assume any obligation to update any forward-looking statements unless required by law.

— Financial Tables Follow —

Energous Corporation
BALANCE SHEETS
(Unaudited)
	As of
	March 31, 2021				December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	44,758,397			$	50,729,661
Accounts receivable, net		156,775				75,850
Prepaid expenses and other current assets		742,193				636,702
Total current assets		45,657,365				51,442,213
Property and equipment, net		449,664				402,711
Right-of-use lease asset		1,097,377				1,293,291
Other assets		1,610				1,610
Total assets	$	47,206,016			$	53,139,825
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,450,767			$	1,096,839
Accrued expenses		1,756,286				1,576,287
Operating lease liabilities, current portion		805,557				825,431
Deferred revenue		17,000				12,000
Total current liabilities		4,029,610				3,510,557
Operating lease liabilities, long-term portion		386,424				576,762
Total liabilities		4,416,034				4,087,319
Stockholders’ equity:
Preferred Stock, $0.00001 par value, 10,000,000 shares authorized at March 31, 2021 and
December 31, 2020; no shares issued or outstanding.		–				–
Common Stock, $0.00001 par value, 200,000,000 shares authorized at March 31, 2021 and
December 31, 2020; 61,919,824 and 61,292,412 shares issued and outstanding at
March 31, 2021 and December 31, 2020, respectively.		620				614
Additional paid-in capital		346,287,871				344,024,638
Accumulated deficit		(303,498,509	)			(294,972,746	)
Total stockholders’ equity		42,789,982				49,052,506
Total liabilities and stockholders’ equity	$	47,206,016			$	53,139,825

Energous Corporation
STATEMENTS OF OPERATIONS
(Unaudited)
		For the Three Months Ended March 31,
		2021				2020
Revenue		$	145,065			$	61,475
Operating expenses:
Research and development			4,591,244				4,575,303
Sales and marketing			1,794,212				1,447,909
General and administrative			2,287,396				2,652,394
Cost of services revenue			–				39,544
Total operating expenses			8,672,852				8,715,150
Loss from operations			(8,527,787	)			(8,653,675	)
Other income (expense):
Interest income			2,024				55,939
Total			2,024				55,939
Net loss		$	(8,525,763	)		$	(8,597,736	)
Basic and diluted net loss per common share		$	(0.14	)		$	(0.25	)
Weighted average shares outstanding, basic and diluted			61,567,003				34,816,553

Energous Corporation
Reconciliation of Non-GAAP Information
(Unaudited)
		For the Three Months Ended March 31,
		2021				2020
Net loss (GAAP)		$	(8,525,763	)		$	(8,597,736	)
Add (subtract) the following items:
Interest income			(2,024	)			(55,939	)
Depreciation and amortization			64,774				121,699
Stock-based compensation			2,146,226				2,276,299
Adjusted EBITDA (non-GAAP)		$	(6,316,787	)		$	(6,255,677	)

 

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Energous Public Relations

[email protected]

(408) 963-0200

Investor Relations Contact

Bishop IR

Mike Bishop

(415) 894-9633

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Electronic Design Automation Engineering Defense Consumer Electronics Technology Manufacturing Mobile/Wireless Office Products Semiconductor Other Energy Retail Utilities Energy Alternative Vehicles/Fuels Aftermarket Automotive Home Goods Other Technology Telecommunications Other Manufacturing Other Defense Hardware

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Epizyme Announces Preclinical and Clinical Data to be Presented in Oral and Poster Sessions at Upcoming Medical Conferences in June

• Oral Presentation of Preclinical Data on Inhibition of SETD2, a Histone Methyltransferase, in Multiple Myeloma to be Presented at the European Hematology Association (EHA) Congress
• Poster Presentation for Tazemetostat, a Methyltransferase Inhibitor, in Epithelioid Sarcoma at the American Society of Clinical Oncology (ASCO) Meeting

CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today announced that new preclinical and clinical data will be presented at upcoming medical meetings in June.

“We look forward to sharing our preclinical data at EHA that provide the therapeutic rationale for targeting SETD2 in multiple myeloma and are so pleased that it has been chosen for an oral presentation. These data are the basis for moving our SETD2 inhibitor program forward and, as we have previously reported, we remain on track for our planned IND submission in mid-2021 and plan to initiate a first-in-human clinical trial by year end,” said Dr. Jeffery Kutok, Epizyme’s Chief Scientific Officer. “As our SETD2 inhibitor program began to take shape, we were struck by the many parallels we saw with our EZH2 inhibitor, TAZVERIK^® (tazemetostat). SETD2 is a histone methyltransferase, like EHZ2, and plays multiple key roles in cellular processes and cancer. We’re excited about the potential of SETD2 inhibition in several settings, including high-risk t(4;14) myeloma, and more broadly in myeloma without the t(4;14) mutation, as well as other B-cell malignancies. We see potential as a monotherapy, as well as in combination with existing and emerging therapies in myeloma, with preclinical data also showing synergy with tazemetostat.”

“We are excited to share safety and preliminary activity data related to the EZH-301 confirmatory study of tazemetostat in Epithelioid Sarcoma (ES) at ASCO, a key milestone toward our goal of demonstrating the benefits of tazemetostat to patients in earlier lines of treatment for ES and Follicular Lymphoma by exploring combinations with standard of care therapies,” said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. “As we outlined during our recent Vision Call, we plan to further explore tazemetostat as both monotherapy and in combinations across multiple hematologic and solid tumor cancers in clinical studies, which are on track to initiate later this year.”

Details of the presentations are listed below:

EHA Oral Presentation

Title: Discovery of a selective inhibitor of the SETD2 histone methyltransferase with potent in vitro and in vivo activity in preclinical models of multiple myeloma

Session: Basic and translational myeloma research

Presenter: Dr. Jennifer Totman

Abstract Code: S176

Live Q&A: Monday, June 14; 2021 8:45-9:30 p.m. CEST/2:45-3:30 p.m. EDT.

The EHA abstracts are available at https://ehaweb.org. All oral and poster presentations will be available on the EHA website on Friday, June 11, 2021 at 9:00 a.m. CEST/3:00 a.m. EDT.

ASCO Poster Presentation

Title: Results of the phase 1b soft-tissue sarcoma (STS) portion of the global randomized, double-blind, placebo-controlled study of tazemetostat (TAZ) plus doxorubicin (DOX) as frontline therapy for advanced epithelioid sarcoma (ES)

Session: Sarcoma

Presenter: Sant P. Chawla, M.D.

Abstract No.: 11563

The ASCO abstracts are available at https://meetinglibrary.asco.org. All oral and poster presentations will be available on the ASCO website on Friday, June 4, 2021 at 9:00 a.m. EDT.

About TAZVERIK^® (tazemetostat)

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 confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) 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 (FL) 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 confirmatory trials(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.

TAZVERIK^® is a registered trademark of Epizyme, Inc.

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: whether commercial sales of TAZVERIK for epithelioid sarcoma and follicular lymphoma in the approved indications will be successful; 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; whether the company will receive 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 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; and other factors discussed in the “Risk Factors” section of the company’s most recent Form 10-K or 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.

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Media:

Erin Graves

Epizyme, Inc.

[email protected]

(617) 500-0615

Investors:

Bill Slattery, Jr.

Real Chemistry

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

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Superior Plus Corp. Announces 2021 First Quarter Results

TORONTO–(BUSINESS WIRE)–
Superior Plus Corp. (“Superior”) (TSX:SPB) announced today its financial and operating results for the first quarter ended March 31, 2021. Unless otherwise expressed, all financial figures are expressed in Canadian dollars.

“We delivered strong financial and operating results in the first quarter with our strategic growth and operational initiatives on-track with our plan,” said Luc Desjardins, President and Chief Executive Officer. “We successfully completed our transition to a pure-play energy distribution company with the sale of the Specialty Chemicals business on April 9, and we have already announced or completed four acquisitions in 2021 for total consideration of $258 million. Our Energy Distribution EBITDA from operations of $216.4 million was a record for the first quarter, demonstrating the continued resiliency of this business.”

Ms. Beth Summers, Executive Vice President and Chief Financial Officer added, “From a financial perspective, we are well-positioned to execute our growth strategy with ample liquidity. To date in 2021, through two high yield issuances and the extension of our credit facility, we have further reduced our debt costs while extending our maturities.”

Financial Highlights:

• Superior achieved first quarter Adjusted EBITDA of $211.6 million, a $26.2 million or 14% increase over the prior year quarter primarily due to higher EBITDA from operations in U.S. propane distribution (“U.S. Propane”) and realized gains on foreign exchange hedging contracts compared to a realized loss in the prior year quarter, partially offset by lower EBITDA from operations in Canadian propane distribution (“Canadian Propane”) and higher corporate costs.
• Net earnings from continuing operations of $75.4 million in the first quarter increased $74.3 million over the first quarter of 2020 primarily due to the factors described above and gains on derivatives and foreign currency translation of borrowings, partially offset by higher finance expense and income tax expense in the current quarter.
• U.S. Propane EBITDA from operations of $140.1 million, increased $36.7 million or 35% from the prior year quarter primarily due to the contribution from acquisitions completed in the last twelve months and colder weather. Average weather, as measured by degree days, across markets where U.S. propane operates for 2021 was 7% colder than the prior year and 4% warmer than the five-year average.
• Canadian Propane EBITDA from operations of $76.3 million, decreased $10.3 million or 12% from the prior year quarter primarily due to lower average margins related to weaker wholesale propane fundamentals and lower sales volumes related to the impact of COVID-19, a decline in oilfield activity in Western Canada and warmer weather. Average weather across Canada for 2021, as measured by degree days was 3% warmer than the prior year and 4% warmer than the five-year average.
• Corporate costs for the first quarter of 2021 were $10.3 million, a $9.7 million increase compared to the prior year quarter due to higher long-term incentive plan costs related to share price appreciation in the current quarter. In the first quarter of 2021, Superior had realized gains on foreign currency hedging contracts of $5.5 million compared to realized losses of $4.0 million in the prior year quarter due to the average hedge rate of the foreign exchange contracts and the strengthening of the Canadian dollar.
• AOCF before transaction and other costs during the first quarter was $185.3 million, a $28.9 million or 18% increase compared to the prior year quarter primarily due to higher Adjusted EBITDA and lower interest expense, partially offset by higher cash tax expenses. AOCF before transaction and other costs per share was $0.90, consistent with the prior year quarter as the increase in AOCF before transaction and other costs was offset by the increase in weighted average shares outstanding. Weighted average shares outstanding, which assumes the exchange of the preferred shares into common shares, were higher than the prior year quarter primarily due to the issuance of preferred shares in the prior year, and to a lesser extent, the impact of shares issued under the Dividend Reinvestment Plan in the prior year.
• Superior’s Total Net Debt to Adjusted EBITDA leverage ratio for the trailing twelve months ended March 31, 2021, including the Specialty Chemicals EBITDA from operations, was 3.6x. The pro forma Net Debt to Adjusted EBITDA leverage ratio, adjusted for the cash proceeds received from the sale of the Specialty Chemicals business and excluding the Specialty Chemicals EBITDA from operations, was 2.9x, which is modestly below Superior’s long-term target range of 3.0x to 3.5x.
• Superior’s outlook for 2021 remains unchanged, with expected Adjusted EBITDA guidance in the previously disclosed guidance range of $370 million to $410 million. Average weather for the remainder of 2021 is anticipated to be consistent with the five-year average for the U.S. and Canada.

Strategic Developments and Highlights:

• On April 27, 2021, Superior entered into an underwriting agreement to issue and sell on a private placement basis CDN$500 million aggregate principal amount of 4.25% unsecured notes due May 18, 2028, which will be issued at par (the “Offering”). Closing of the Offering is expected to occur on or about May 18, 2021, subject to customary closing conditions. Superior also issued conditional redemption notices to redeem all of its outstanding: (i) CDN$400 million principal amount of 5.25% senior unsecured notes due February 27, 2024 (the “2024 Notes”) in accordance with the indenture governing the 2024 Notes; and (ii) CDN$370 million principal amount of 5.125% senior unsecured notes due August 27, 2025 (the “2025 Notes”) in accordance with the indenture governing the 2025 Notes.
• On April 22, 2021, Superior entered into an agreement to acquire the assets of a retail propane distribution company based in South Carolina, operating under the tradename, Freeman Gas and Electric Co., Inc. (“Freeman”) for an aggregate purchase price of approximately US $170 million ($213 million) before adjustments for working capital. Superior anticipates using available cash to fund the amount of the purchase price due on closing.
• On April 19, 2021, recognizing the importance of sustainability and ESG principles in how Superior operates and in its business strategy, Superior published its inaugural Sustainability Report.
• On April 9, 2021, Superior amended the syndicated credit facility and extended the maturity to May 8, 2026. There were no changes to the total commitments available under the credit facility ($750 million), the accordion capacity ($300 million) or the financial covenants.
• On April 9, 2021, Superior completed the sale of its Specialty Chemicals business to Birch Hill Equity Partners for total consideration of $725 million (the “Transaction”). Under the terms of the Transaction, Superior received $600 million in cash proceeds from Birch Hill, subject to certain adjustments, and $125 million in the form of a 6% unsecured note issued by the affiliate of Birch Hill that is acquiring Specialty Chemicals. The consideration received is subject to certain post-closing adjustments as previously disclosed.
• On March 11, 2021, Superior closed the private placement of US$600 million principal amount of 4.500% Senior Unsecured Notes due March 15, 2029, which were issued at par. Superior also completed the redemption of the US$350 million 7.000% senior unsecured notes due July 15, 2026 at a redemption price of 107.444% of the outstanding principal amount, plus accrued and unpaid interest to, but excluding, the redemption date.
• On February 11, 2021, Superior acquired the assets of an Ontario retail propane distribution company, operating under the tradename Highlands Propane (“Highlands”) for a total consideration of approximately $15.0 million.
• On February 1, 2021, Superior acquired a 100% equity interest of a retail propane distribution company, operating in Quebec under the tradename Miller Propane (“Miller”) for a total consideration of $7.5 million.
• On January 26, 2021, Superior announced the acquisition of the assets of a retail propane and distillate distribution company, operating in Massachusetts under the tradename Holden Oil (“Holden”) for total consideration of US$17.5 million ($22.3 million).

Financial Overview
			Three Months Ended
			March 31
(millions of dollars, except per share amounts)			2021			2020(1)
Revenue			839.5			682.6
Gross Profit			349.1			346.2
Net earnings from continuing operations			75.4			1.1
Net earnings per share, basic and diluted (4)		$	0.36		$	0.01
EBITDA from operations (2)			216.4			190.0
Adjusted EBITDA (2)			211.6			185.4
Cash flows from operating activities			126.1			84.8
Cash flows from operating activities per share – basic and diluted (4)		$	0.61		$	0.48
AOCF before transaction and other costs (2)(3)			185.3			156.4
AOCF before transaction and other costs per share – basic and diluted (2)(3)(4)		$	0.90		$	0.89
AOCF (2)			175.9			151.2
AOCF per share– basic and diluted (2)(4)		$	0.85		$	0.86
Cash dividends declared on common shares			31.7			31.2
Cash dividends declared per share		$	0.18		$	0.18

(1)		Comparative figures have been reclassified to exclude the results of the Specialty Chemicals segment due to the divestiture of the segment subsequent to the end of the first quarter. See the unaudited condensed interim consolidated financial statements for the quarter ended March 31, 2021.
(2)		EBITDA from operations, Adjusted EBITDA, AOCF before transaction and other costs, and AOCF are Non-GAAP measures. See “Non-GAAP Financial Measures”.
(3)		Transaction and other costs for the three months ended March 31, 2021 and 2020 are related to acquisition activity, restructuring and the integration of acquisitions and the divestiture of the Specialty Chemical segment. See “Transaction and Other Costs” for further details.
(4)		The weighted average number of shares outstanding for the three months ended March 31, 2021 was 206.0 million (March 31, 2020 was 174.9 million). The weighted average number of shares assumes the exchange of the preferred shares into common shares. There were no other dilutive instruments with respect to AOCF per share and AOCF before transaction and other costs per share for the three months ended March 31, 2021 and 2020.

Segmented Information
			Three Months Ended
			March 31
	(millions of dollars)			2021		2020
	EBITDA from operations (1)
		U.S. Propane Distribution		140.1		103.4
		Canadian Propane Distribution		76.3		86.6
				216.4		190.0

(1)

See “Non-GAAP Financial Measures”.

MD&A and Financial Statements

Superior’s MD&A, the unaudited Interim Consolidated Financial Statements and the Notes to the Interim Consolidated Financial Statements for the three months ended March 31, 2021 provide a detailed explanation of Superior’s operating results. These documents are available online at Superior’s website at www.superiorplus.com under the Investor Relations section and on SEDAR under Superior’s profile at www.sedar.com.

Virtual Annual General Meeting

Due to the COVID-19 pandemic and the directives from public health and other government authorities to maintain physical distance and eliminate social gatherings, we are holding our annual meeting in a virtual-only format so shareholders may attend and participate in the annual meeting via live webcast on Wednesday, May 12, 2021 at 4:00 PM EDT. Please see Superior’s website at www.superiorplus.com for detailed instructions.

2021 First Quarter Conference Call

Superior will be conducting a conference call and webcast for investors, analysts, brokers and media representatives to discuss the First Quarter Results at 10:30 a.m. EDT on Thursday, May 13, 2021. To participate in the call, dial: 1-844-389-8661. Internet users can listen to the call live, or as an archived call on Superior’s website at www.superiorplus.com under the Events section.

2021 Virtual Investor Day

Superior will host a virtual Investor Day on May 25, 2021 at 1 p.m. EDT. During the event, members of the executive leadership team will provide an update on Superior’s markets and businesses, strategic transformational initiative, the Superior Way Forward, and future financial outlook. For parties interested in attending the event, please email [email protected]. A link to the webcast along with the agenda for the event will be emailed to all participants and will also be posted on Superior’s website in the “Events” section closer to the time of Investor Day.

Non-GAAP Financial Measures

Throughout the first quarter earnings release, Superior has used the following terms that are not defined by International Financial Reporting Standards (“Non-GAAP Financial Measures”), but are used by management to evaluate the performance of Superior and its business: AOCF before and after transaction and other costs, earnings before interest, taxes, depreciation and amortization (“EBITDA”) from operations, Adjusted Gross Profit, Adjusted EBITDA, Total Debt to Adjusted EBITDA leverage ratio, Senior Debt, Credit Facility EBITDA and Senior Debt to Credit Facility EBITDA leverage ratio. These measures may also be used by investors, financial institutions and credit rating agencies to assess Superior’s performance and ability to service debt. Non-GAAP financial measures do not have standardized meanings prescribed by GAAP and are therefore unlikely to be comparable to similar measures presented by other companies. Securities regulations require that Non-GAAP financial measures are clearly defined, qualified and reconciled to their most comparable GAAP financial measures. Except as otherwise indicated, these Non-GAAP financial measures are calculated and disclosed on a consistent basis from period to period. Specific items may only be relevant in certain periods. See “Non-GAAP Financial Measures” in the MD&A for a discussion of Non-GAAP financial measures and certain reconciliations to GAAP financial measures.

The intent of Non-GAAP financial measures is to provide additional useful information to investors and analysts, and the measures do not have any standardized meaning under IFRS. The measures should not, therefore, be considered in isolation or used in substitute for measures of performance prepared in accordance with IFRS. Other issuers may calculate Non-GAAP financial measures differently. Investors should be cautioned that AOCF, EBITDA from operations, Adjusted EBITDA and Credit Facility EBITDA should not be construed as alternatives to net earnings, cash flow from operating activities or other measures of financial results determined in accordance with GAAP as an indicator of Superior’s performance.

Adjusted Operating Cash Flow and Adjusted Operating Cash Flow per Share

AOCF is equal to cash flow from operating activities as defined by IFRS, adjusted for changes in non-cash working capital, other expenses, non-cash interest expense, current income taxes and finance costs. Superior may deduct or include additional items in its calculation of AOCF; these items would generally, but not necessarily, be infrequent in nature and could distort the analysis of trends in business performance. Excluding these items does not imply they are non-recurring. AOCF and AOCF per share are presented before and after transaction and other costs.

AOCF per share before transaction and other costs is calculated by dividing AOCF before transaction and other costs by the weighted average number of shares outstanding. AOCF per share is calculated by dividing AOCF by the weighted average number of shares outstanding.

AOCF is a performance measure used by management and investors to evaluate Superior’s ongoing performance of its businesses and ability to generate cash flow. AOCF represents cash flow generated by Superior that is available for, but not necessarily limited to, changes in working capital requirements, investing activities and financing activities of Superior.

The seasonality of Superior’s individual quarterly results must be assessed in the context of annualized AOCF. Adjustments recorded by Superior as part of its calculation of AOCF include, but are not limited to, the impact of the seasonality of Superior’s businesses by adjusting for non-cash working capital items, thereby eliminating the impact of the timing between the recognition and collection/payment of Superior’s revenues and expenses, which can differ significantly from quarter to quarter. AOCF is reconciled to cash flow from operating activities. Please refer to the Financial Overview section of the MD&A for the reconciliation.

EBITDA from operations

EBITDA from operations is defined as Adjusted EBITDA excluding costs that are not considered representative of Superior’s underlying core operating performance, including gains and losses on foreign currency hedging contracts, corporate costs and transaction and other costs. Management uses EBITDA from operations to set targets for Superior (including annual guidance and variable compensation targets). EBITDA from operations is reconciled to net earnings before income taxes. Please refer to the Results of Operating Segments in the MD&A for the reconciliations.

Adjusted EBITDA

Adjusted EBITDA represents earnings before interest, taxes, depreciation, amortization, losses (gains) on disposal of assets, finance expense, restructuring costs, transaction and other costs, and unrealized gains (losses) on derivative financial instruments. Adjusted EBITDA is used by Superior and investors to assess its consolidated results and ability to service debt. Adjusted EBITDA is reconciled to net earnings before income taxes.

Adjusted EBITDA is a significant performance measure used by management and investors to evaluate Superior’s ongoing performance of its businesses. Adjusted EBITDA is also used as one component in determining short-term incentive compensation for certain management employees.

The seasonality of Superior’s individual quarterly results must be assessed in the context of annualized Adjusted EBITDA.

Total Net Debt to Adjusted EBITDA Leverage Ratio and Pro Forma Adjusted EBITDA

Adjusted EBITDA for the Total Net Debt to Adjusted EBITDA Leverage Ratio is defined as Adjusted EBITDA calculated on a 12-month trailing basis giving pro forma effect to acquisitions and dispositions adjusted to the first day of the calculation period (“Pro Forma Adjusted EBITDA”). Pro Forma Adjusted EBITDA is used by Superior to calculate its Total Net Debt to Adjusted EBITDA Leverage Ratio.

To calculate the Total Net Debt to Adjusted EBITDA Leverage Ratio divide the sum of borrowings before deferred financing fees and lease liabilities by Pro Forma Adjusted EBITDA. The Total Net Debt to Adjusted EBITDA Leverage Ratio is used by Superior and investors to assess its ability to service debt.

Forward Looking Information

Certain information included herein is forward-looking information within the meaning of applicable Canadian securities laws. Forward-looking information may include statements regarding the objectives, business strategies to achieve those objectives, expected financial results (including those in the area of risk management), economic or market conditions, and the outlook of or involving Superior, Superior LP and its businesses. Such information is typically identified by words such as “anticipate”, “believe”, “continue”, “estimate”, “expect”, “plan”, “forecast”, “future”, “outlook, “guidance”, “may”, “project”, “should”, “strategy”, “target”, “will” or similar expressions suggesting future outcomes.

Forward-looking information in this document includes: future financial position, consolidated and business segment outlooks, expected Adjusted EBITDA, the markets for our products and our financial results, business strategy and objectives, development plans and programs, organic growth, weather, economic activity in Western Canada, product pricing and sourcing, wholesale propane market fundamentals, exchange rates, expected seasonality of demand, and future economic conditions.

Forward-looking information is provided for the purpose of providing information about management’s expectations and plans about the future and may not be appropriate for other purposes. Forward-looking information herein is based on various assumptions and expectations that Superior believes are reasonable in the circumstances. No assurance can be given that these assumptions and expectations will prove to be correct. Those assumptions and expectations are based on information currently available to Superior, including information obtained from third party industry analysts and other third party sources, and the historic performance of Superior’s businesses. Such assumptions include anticipated financial performance, current business and economic trends, the amount of future dividends paid by Superior, business prospects, utilization of tax basis, regulatory developments, currency, exchange and interest rates, future commodity prices relating to the oil and gas industry, future oil rig activity levels, trading data, cost estimates, our ability to obtain financing on acceptable terms, expected life of facilities and statements regarding net working capital and capital expenditure requirements of Superior or Superior LP, the assumptions set forth under the “Financial Outlook” sections of our MD&A. The forward looking information is also subject to the risks and uncertainties set forth below.

By its very nature, forward-looking information involves numerous assumptions, risks and uncertainties, both general and specific. Should one or more of these risks and uncertainties materialize or should underlying assumptions prove incorrect, as many important factors are beyond our control, Superior’s or Superior LP’s actual performance and financial results may vary materially from those estimates and intentions contemplated, expressed or implied in the forward-looking information. These risks and uncertainties include incorrect assessments of value when making acquisitions, increases in debt service charges, the loss of key personnel, the anticipated impact of the COVID-19 pandemic and the expected economic recession, fluctuations in foreign currency and exchange rates, inadequate insurance coverage, liability for cash taxes, counterparty risk, compliance with environmental laws and regulations, reduced customer demand, operational risks involving our facilities, force majeure, labour relations matters, our ability to access external sources of debt and equity capital, and the risks identified in (i) our MD&A under the heading “Risk Factors” and (ii) Superior’s most recent Annual Information Form. The preceding list of assumptions, risks and uncertainties is not exhaustive.

When relying on our forward-looking information to make decisions with respect to Superior, investors and others should carefully consider the preceding factors, other uncertainties and potential events. Any forward-looking information is provided as of the date of this document and, except as required by law, neither Superior nor Superior LP undertakes to update or revise such information to reflect new information, subsequent or otherwise. For the reasons set forth above, investors should not place undue reliance on forward-looking information.

For more information about Superior, visit our website at www.superiorplus.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210512005949/en/

Beth Summers ExecutiveVice President and Chief Financial Officer

Phone: (416) 340-6015

Rob Dorran Vice President, Investor Relations and Treasurer

Phone: (416) 340-6003

Toll Free: 1-866-490-PLUS (7587)

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Chemicals/Plastics Mining/Minerals Utilities Manufacturing Energy Natural Resources

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