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Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast

Revance Reports Second Quarter 2022 Financial Results, Provides Corporate Update


Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today reported financial results for the second quarter ended June 30, 2022 and provided a corporate update.

Financial Highlights

"We are very pleased with our second quarter financial results, highlighted by our best performing quarter for the RHA® Collection and steady account growth across our portfolio. These results not only reflect the continued success of our launch and ability to gain share, but also the resilience of the facial injectables market," said Mark J. Foley, Chief Executive Officer of Revance. "We expect to continue to build on our commercial success and are excited about the launch of RHA® Redensity, the latest innovation from our RHA® Collection of dermal fillers."

Foley added, "Importantly, we are looking forward to our September 8th PDUFA date for DaxibotulinumtoxinA of Injection for glabellar lines and I am very appreciative and proud of the team for all of their hard work in supporting the reinspection of our manufacturing facility."

Second Quarter Highlights and Subsequent Updates

2022 Financial Outlook

Revance expects 2022 GAAP operating expenses to be $375 million to $400 million and non-GAAP operating expenses, which exclude costs of revenue, depreciation, amortization and stock-based compensation to be $260 million to $280 million. Revance expects 2022 non-GAAP research and development expense to be $100 million to $110 million. With the current cash, cash equivalents and short-term investments of $233.8 million, management projects that the company is funded into 2024, with an additional $100 million in notes available under the company's note purchase agreement, subject to the FDA approval of DaxibotulinumtoxinA for Injection for glabellar lines.

Conference Call

Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on August 9, 2022 to discuss the results and provide a business update. Individuals interested in listening to the conference call may do so by registering via the webcast link in the investor relations section of the company's website at: www.revance.com.

To access the call by phone, please use this registration link, and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. A webcast replay will be available in the investor relations section on the company's website for 90 days following the completion of the call.

1.

 

Fintech platform refers to the OPULtm Relational Commerce Platform and the company's legacy HintMD Platform. The company is in the process of migrating existing HintMD customers to the OPULtm platform.

About Revance

Revance is a commercial stage biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation, long-acting neuromodulator product, DaxibotulinumtoxinA for Injection. Revance has successfully completed Phase 3 clinical programs for DaxibotulinumtoxinA for Injection in glabellar (frown) lines, for which the company is currently pursuing U.S. regulatory approval, and in cervical dystonia. Revance is also evaluating DaxibotulinumtoxinA for Injection in adult upper limb spasticity. Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the OPULtm Relational Commerce Platform. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which if approved, would be the first and only generic biosimilar to Botox® and Botox® Cosmetic. For more information or to join our team visit us at www.revance.com.

"Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.
BOTOX® is a registered trademark of Allergan, Inc.

Forward Looking Statements

Any statements in this press release that are not statements of historical fact, including statements related to our 2022 financial outlook, future expenses, expected cash runway and financial performance; our PDUFA date, our confidence in our responses to the FDA observations and our ability to address deficiencies identified by the FDA and obtain regulatory approval of DaxibotulinumtoxinA for Injection in glabellar lines; our ability to obtain, and the timing relating to regulatory submissions and approvals with respect to our drug product candidates; the RHA® Redensity launch; the potential label expansion of RHA® Redensity; the safety, efficacy and duration of DaxibotulinumtoxinA for Injection; development of a biosimilar to BOTOX® with our partner, Viatris; our business strategy, timeline and other goals, plans and prospects, including our commercialization plans; the potential benefits of our drug product candidates and our technologies, including DaxibotulinumtoxinA for Injection, the RHA® Collection of dermal fillers and the fintech platform; the extent to which our products and services are considered differentiated; and the market for and growth potential of aesthetic accounts, OPULtm, the RHA® Collection of dermal fillers and our dug product candidates, if approved, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, our ability to remediate deficiencies identified by the FDA and obtain FDA approval of the BLA for DaxibotulinumtoxinA for Injection for glabellar lines, including as a result of observations made by the FDA during the site inspection or other reasons; our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding expenses, future revenues, capital requirements, our financial performance and the economics of DaxibotulinumtoxinA for Injection, the RHA® Collection of dermal fillers and OPULtm; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products and services, the aesthetics market, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability and the ability of our partners to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, commercial acceptance, market, competition and/or size and growth potential of the RHA® Collection of dermal fillers, OPULtm and our drug product candidates, if approved; our ability to continue to successfully commercialize the RHA® Collection of dermal fillers and OPULtm and our ability to successfully commercialize DaxibotulinumtoxinA for Injection, if approved, and the timing and cost of commercialization activities; the proper training and administration of our products by physicians and medical staff; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with privacy and data protection laws; our ability to effectively manage our expanded operations in connection with the acquisition of Hint, Inc; the profitability of and our ability to scale OPULtm, the features and functionalities and benefits to practices and patients of OPULtm; interruptions or performance problems associated with HintMD or OPULtm; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; the volatility of our stock price; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-K filed with the SEC on February 28, 2022 and including, without limitation, our Form 10-Q for the quarter ended June 30, 2022, expected to be filed with the SEC on August 9, 2022. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

Use of Non-GAAP Financial Measures

Revance has presented certain non-GAAP financial measures in this release. This release and the reconciliation tables included herein include non-GAAP selling, general and administrative expenses, which excludes depreciation, amortization and stock-based compensation; non-GAAP R&D expense, which excludes depreciation, amortization and non-cash stock-based compensation; and total non-GAAP operating expense, which excludes costs of revenue, depreciation, amortization and stock-based compensation. Revance excludes costs of revenue, depreciation, amortization and stock-based compensation because management believes the exclusion of these items is helpful to investors to evaluate Revance's recurring operational performance. Revance management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results.

Certain non-GAAP measures included in this release were not reconciled to the comparable GAAP financial measures because the GAAP measures are not accessible on a forward-looking basis. The company is unable to reconcile these forward-looking non-GAAP financial measures to the most directly comparable GAAP measures without unreasonable efforts because the company is currently unable to predict with a reasonable degree of certainty the type and extent of certain items that would be expected to impact GAAP measures for these periods but would not impact the non-GAAP measures. Such items include costs of revenue, depreciation, amortization, and stock-based compensation. The unavailable information could have a significant impact on the company's GAAP financial results.

REVANCE THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)

 

 

June 30,

 

December 31,

 

2022

 

2021

ASSETS

CURRENT ASSETS

 

 

 

Cash and cash equivalents

$

69,418

 

 

$

110,623

 

Short-term investments

 

164,397

 

 

 

114,448

 

Accounts receivable, net

 

5,590

 

 

 

3,348

 

Inventories

 

13,600

 

 

 

10,154

 

Prepaid expenses and other current assets

 

7,940

 

 

 

7,544

 

Total current assets

 

260,945

 

 

 

246,117

 

Property and equipment, net

 

22,595

 

 

 

24,661

 

Goodwill

 

146,964

 

 

 

146,964

 

Intangible assets, net

 

47,022

 

 

 

55,334

 

Operating lease right-of-use assets

 

41,802

 

 

 

44,340

 

Finance lease right-of-use asset

 

17,398

 

 

 

?

 

Restricted cash

 

5,921

 

 

 

5,046

 

Other non-current assets

 

19,236

 

 

 

8,701

 

TOTAL ASSETS

$

561,883

 

 

$

531,163

 

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

CURRENT LIABILITIES

 

 

 

Accounts payable

$

13,272

 

 

$

10,603

 

Accruals and other current liabilities

 

27,469

 

 

 

39,558

 

Deferred revenue, current

 

10,665

 

 

 

9,362

 

Finance lease liability, current

 

17,720

 

 

 

?

 

Operating lease liabilities, current

 

4,975

 

 

 

4,746

 

Derivative liability

 

3,125

 

 

 

3,020

 

Total current liabilities

 

77,226

 

 

 

67,289

 

Debt, non-current

 

378,383

 

 

 

280,635

 

Deferred revenue, non-current

 

69,605

 

 

 

74,152

 

Operating lease liabilities, non-current

 

36,613

 

 

 

39,131

 

Other non-current liabilities

 

2,687

 

 

 

1,485

 

TOTAL LIABILITIES

 

564,514

 

 

 

462,692

 

STOCKHOLDERS' EQUITY (DEFICIT)

 

 

 

Convertible preferred stock, par value $0.001 per share ? 5,000,000 shares authorized, and no shares issued and outstanding as of June 30, 2022 and December 31, 2021

 

?

 

 

 

?

 

Common stock, par value $0.001 per share ? 190,000,000 shares authorized both as of June 30, 2022 and December 31, 2021; 73,123,363 and 71,584,057 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

 

73

 

 

 

72

 

Additional paid-in capital

 

1,521,411

 

 

 

1,466,369

 

Accumulated other comprehensive loss

 

(386

)

 

 

(18

)

Accumulated deficit

 

(1,523,729

)

 

 

(1,397,952

)

TOTAL STOCKHOLDERS' EQUITY (DEFICIT)

 

(2,631

)

 

 

68,471

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

$

561,883

 

 

$

531,163

 

REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

2022

 

2021

 

2022

 

2021

Revenue:

 

 

 

 

 

 

 

Product revenue

$

25,483

 

 

$

17,039

 

 

$

46,320

 

 

$

28,686

 

Collaboration revenue

 

1,659

 

 

 

1,394

 

 

 

5,227

 

 

 

2,905

 

Service revenue

 

1,226

 

 

 

371

 

 

 

2,082

 

 

 

512

 

Total revenue

 

28,368

 

 

 

18,804

 

 

 

53,629

 

 

 

32,103

 

Operating expenses:

 

 

 

 

 

 

 

Cost of product revenue (exclusive of amortization)

 

8,121

 

 

 

5,409

 

 

 

15,449

 

 

 

9,626

 

Cost of service revenue (exclusive of amortization)

 

1,402

 

 

 

17

 

 

 

1,967

 

 

 

17

 

Selling, general and administrative

 

47,847

 

 

 

50,598

 

 

 

92,922

 

 

 

99,603

 

Research and development

 

24,913

 

 

 

29,441

 

 

 

55,642

 

 

 

56,692

 

Amortization

 

3,927

 

 

 

3,676

 

 

 

7,712

 

 

 

6,514

 

Total operating expenses

 

86,210

 

 

 

89,141

 

 

 

173,692

 

 

 

172,452

 

Loss from operations

 

(57,842

)

 

 

(70,337

)

 

 

(120,063

)

 

 

(140,349

)

Interest income

 

619

 

 

 

85

 

 

 

695

 

 

 

182

 

Interest expense

 

(3,874

)

 

 

(1,569

)

 

 

(5,805

)

 

 

(3,129

)

Changes in fair value of derivative liability

 

(61

)

 

 

(19

)

 

 

(105

)

 

 

(78

)

Other expense, net

 

(277

)

 

 

(357

)

 

 

(499

)

 

 

(462

)

Net loss

 

(61,435

)

 

 

(72,197

)

 

 

(125,777

)

 

 

(143,836

)

Unrealized loss

 

(327

)

 

 

(2

)

 

 

(368

)

 

 

(2

)

Comprehensive loss

$

(61,762

)

 

$

(72,199

)

 

$

(126,145

)

 

$

(143,838

)

Basic and diluted net loss

$

(61,435

)

 

$

(72,197

)

 

$

(125,777

)

 

$

(143,836

)

Basic and diluted net loss per share

$

(0.88

)

 

$

(1.07

)

 

$

(1.82

)

 

$

(2.15

)

Basic and diluted weighted-average number of shares used in computing net loss per share

 

70,061,457

 

 

 

67,462,413

 

 

 

69,202,062

 

 

 

67,051,902

 

REVANCE THERAPEUTICS, INC.

Reconciliation of GAAP SG&A Expense to Non-GAAP SG&A Expense

(In thousands)

(Unaudited)

 

 

Three Months Ended

 

Six Months Ended

 

June 30, 2022

 

June 30, 2022

SG&A expense:

 

 

 

GAAP SG&A expense

$

47,847

 

 

$

92,922

 

Adjustments:

 

 

 

Stock-based compensation

 

(6,528

)

 

 

(14,692

)

Depreciation and amortization

 

(1,018

)

 

 

(2,152

)

Non-GAAP SG&A expense

$

40,301

 

 

$

76,078

 

REVANCE THERAPEUTICS, INC.
Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense
(In thousands)
(Unaudited)

 

 

Three Months Ended

 

Six Months Ended

 

June 30, 2022

 

June 30, 2022

R&D expense:

 

 

 

GAAP R&D expense

$

24,913

 

 

$

55,642

 

Adjustments:

 

 

 

Stock-based compensation

 

(2,735

)

 

 

(8,934

)

Depreciation and amortization

 

(506

)

 

 

(963

)

Non-GAAP R&D expense

$

21,672

 

 

$

45,745

 

REVANCE THERAPEUTICS, INC.
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense
(In thousands)
(Unaudited)

 

 

Three Months Ended

 

Six Months Ended

 

June 30, 2022

 

June 30, 2022

Operating expense:

 

 

 

GAAP operating expense

$

86,210

 

 

$

173,692

 

Adjustments:

 

 

 

Stock-based compensation

 

(9,263

)

 

 

(23,626

)

Depreciation and amortization

 

(5,451

)

 

 

(10,827

)

Costs of revenue (exclusive of amortization)

 

(9,523

)

 

 

(17,416

)

Non-GAAP operating expense

$

61,973

 

 

$

121,823

 

 


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