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

Revance Reports Second Quarter 2020 Financial Results, Provides Corporate Update


Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today reported financial results for the quarter ended June 30, 2020, and provided a corporate update.

Key Second Quarter 2020 and Subsequent Updates

"The second quarter was a transformational period for the company, marked by many significant accomplishments, despite the challenges resulting from the COVID-19 pandemic. Of particular note was the acquisition of HintMD, which provides us with an exciting and complementary fintech platform that will meaningfully enhance our ability to partner with aesthetic practices, deliver incremental value, and provide Revance with a healthy source of recurring revenue," said Mark Foley, President and Chief Executive Officer. "Looking ahead to the second half of 2020, we enter a catalyst-rich period, beginning with the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform in September. Then, in the fall, we plan to report the topline results from our ASPEN-1 Phase 3 cervical dystonia trial and Phase 2 plantar fasciitis study. Lastly, we remain on track for potential U.S. regulatory approval of DaxibotulinumtoxinA for Injection, in the treatment of glabellar lines, in November. As we make the transition from a pre-commercial to a commercial entity, I am incredibly excited about our future and firmly believe that we have the right people, products and strategy in place to successfully compete in both the aesthetic and therapeutic markets."

Financial Highlights

Cash, cash equivalents and short-term investments as of June 30, 2020 were $494.0 million.

Revenue for the quarter ended June 30, 2020 was $0.3 million with no revenue recognized in the same period in 2019. Revenue for the six months ended June 30, 2020 was $0.4 million compared to $0.3 million for the same period in 2019. Revenue recognized for the quarter consists of both the initial sale of the RHA® Collection of dermal fillers in connection with the PrevU Program and activities related to the Mylan collaboration for the biosimilar to BOTOX® program.

Cost of revenue (exclusive of amortization) for the quarter is minimal and is related to cost of RHA® Collection inventory delivered as part of the PrevU Program.

Research and development expenses for the three and six months ended June 30, 2020 were $27.1 million and $66.9 million compared to $25.5 million and $49.5 million for the same periods in 2019, respectively. A non-cash acquisition charge of $11.2 million was allocated to in-process research and development from the TEOXANE distribution agreement in the first quarter of 2020.

Selling, general and administrative expenses for the three and six months ended June 30, 2020 were $29.6 million and $50.8 million compared to $13.6 million and $26.5 million for the same periods in 2019, respectively. The increase in selling, general and administrative expenses is primarily due to increased costs related to commercial activities, HintMD acquisition related costs, human capital, and infrastructure build-out.

Total operating expenses for the three and six months ended June 30, 2020 were $57.4 million and $118.4 million compared to $39.1 million and $76.0 million for the same periods in 2019, respectively. Depreciation and amortization for the three and six months ended June 30, 2020 was $1.4 million and $2.2 million, respectively. Stock-based compensation for the three and six months ended June 30, 2020 was $7.4 million and $13.9 million, respectively. When excluding depreciation and amortization, stock-based compensation, and non-cash in-process research and development, total operating expenses for the three and six months ended June 30, 2020 were $48.6 million and $91.2 million, respectively.

Net loss for the three and six months ended June 30, 2020 was $60.6 million and $122.5 million compared to $37.4 million and $72.7 million for the same periods in 2019, respectively.

Near-Term Milestone Expectations

Aesthetics:

Therapeutics:

2020 Financial Outlook

We are developing our acquisition accounting for HintMD and once completed we can provide GAAP operating expense guidance for 2020. Nevertheless, Revance expects non-GAAP (U.S. generally accepted accounting principles, or GAAP) operating expense, which excludes depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs, to be in the range of $220 to $230 million. With multiple clinical programs underway, along with regulatory and pre-commercial manufacturing activities, Revance anticipates 2020 non-GAAP, non-HintMD related research and development expense to be $95 to $100 million. With current cash and equivalents, management projects that the company is funded into 2023.

Conference Call

Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 4968933; or from the webcast link in the investor relations section of the company's website at: www.revance.com. A replay of the call will be available beginning August 6, 2020 at 4:30 p.m. PT/7:30 p.m. ET to August 7, 2020 at 4:30 p.m. PT/7:30 p.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 4968933.

The live webcast can be accessed here and will be available in the investor relations section on the company's website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Revance requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone.

About Revance Therapeutics, Inc.

Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, 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 HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. 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

This press release contains forward-looking statements, including statements related to Revance's financial outlook, milestone expectations, expected cash runway and financial performance; the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. 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 Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risks Factors" in the Registration Statement on Form S-4/A filed with the SEC on June 23, 2020. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims 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 total non-GAAP operating expense and non-GAAP R&D expense, both of which exclude depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs. Revance excludes depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs 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.

 

REVANCE THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

 

June 30,

 

December 31,

 

2020

 

 

2019

 

ASSETS

CURRENT ASSETS

 

 

 

Cash and cash equivalents

$

363,511

 

 

 

$

171,160

 

 

Short-term investments

130,532

 

 

 

118,955

 

 

Accounts receivable

49

 

 

 

?

 

 

Inventories

778

 

 

 

?

 

 

Prepaid expenses and other current assets

7,901

 

 

 

6,487

 

 

Total current assets

502,771

 

 

 

296,602

 

 

Property and equipment, net

13,695

 

 

 

14,755

 

 

Intangible assets, net

31,660

 

 

 

?

 

 

Operating lease right of use assets

25,366

 

 

 

26,531

 

 

Restricted cash

1,050

 

 

 

730

 

 

Other non-current assets

1,639

 

 

 

1,669

 

 

TOTAL ASSETS

$

576,181

 

 

 

$

340,287

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

CURRENT LIABILITIES

 

 

 

Accounts payable

$

6,603

 

 

 

$

8,010

 

 

Accruals and other current liabilities

22,245

 

 

 

18,636

 

 

Deferred revenue, current portion

12,255

 

 

 

7,911

 

 

Operating lease liabilities, current portion

3,789

 

 

 

3,470

 

 

Derivative liability

3,101

 

 

 

2,952

 

 

Total current liabilities

47,993

 

 

 

40,979

 

 

Convertible senior notes

174,304

 

 

 

?

 

 

Deferred revenue, net of current portion

74,295

 

 

 

47,948

 

 

Operating lease liabilities, net of current portion

23,871

 

 

 

25,870

 

 

TOTAL LIABILITIES

320,463

 

 

 

114,797

 

 

STOCKHOLDERS' EQUITY

 

 

 

Convertible preferred stock, par value $0.001 per share ? 5,000,000 shares authorized, and no shares issued and outstanding as of June 30, 2020 and December 31, 2019

?

 

 

 

?

 

 

Common stock, par value $0.001 per share ? 95,000,000 shares authorized both as of June 30, 2020 and December 31, 2019; 57,313,556 and 52,374,735 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively

57

 

 

 

52

 

 

Additional paid-in capital

1,222,271

 

 

 

1,069,639

 

 

Accumulated other comprehensive income

117

 

 

 

3

 

 

Accumulated deficit

(966,727

)

 

 

(844,204

)

 

TOTAL STOCKHOLDERS' EQUITY

255,718

 

 

 

225,490

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

$

576,181

 

 

 

$

340,287

 

 

 

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,

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue

$

299

 

 

 

$

?

 

 

 

$

357

 

 

 

$

278

 

 

Operating expenses:

 

 

 

 

 

 

 

Cost of revenue (exclusive of amortization)

21

 

 

 

?

 

 

 

21

 

 

 

?

 

 

Research and development

27,103

 

 

 

25,526

 

 

 

66,897

 

 

 

49,521

 

 

Selling, general and administrative

29,606

 

 

 

13,596

 

 

 

50,830

 

 

 

26,506

 

 

Amortization

674

 

 

 

?

 

 

 

674

 

 

 

?

 

 

Total operating expenses

57,404

 

 

 

39,122

 

 

 

118,422

 

 

 

76,027

 

 

Loss from operations

(57,105

)

 

 

(39,122

)

 

 

(118,065

)

 

 

(75,749

)

 

Interest income

964

 

 

 

1,596

 

 

 

2,455

 

 

 

3,166

 

 

Interest expense

(4,256

)

 

 

?

 

 

 

(6,404

)

 

 

?

 

 

Changes in fair value of derivative liability

(59

)

 

 

21

 

 

 

(149

)

 

 

(71

)

 

Other income (expense), net

(134

)

 

 

115

 

 

 

(260

)

 

 

(40

)

 

Loss before income taxes

(60,590

)

 

 

(37,390

)

 

 

(122,423

)

 

 

(72,694

)

 

Income tax provision

?

 

 

 

?

 

 

 

(100

)

 

 

?

 

 

Net loss

(60,590

)

 

 

(37,390

)

 

 

(122,523

)

 

 

(72,694

)

 

Unrealized gain (loss) and adjustment on securities included in net loss

(407

)

 

 

46

 

 

 

114

 

 

 

124

 

 

Comprehensive loss

$

(60,997

)

 

 

$

(37,344

)

 

 

$

(122,409

)

 

 

$

(72,570

)

 

Basic and diluted net loss

$

(60,590

)

 

 

$

(37,390

)

 

 

$

(122,523

)

 

 

$

(72,694

)

 

Basic and diluted net loss per share

$

(1.12

)

 

 

$

(0.86

)

 

 

$

(2.27

)

 

 

$

(1.71

)

 

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

54,257,320

 

 

 

43,260,317

 

 

 

54,062,678

 

 

 

42,434,137

 

 

 

REVANCE THERAPEUTICS, INC.

Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense

(In thousands)

(Unaudited)

 

 

Three Months Ended

 

Six Months Ended

 

June 30, 2020

 

June 30, 2020

Operating expense:

 

 

 

GAAP operating expense

$

57,404

 

 

 

$

118,422

 

 

Adjustments:

 

 

 

In-process research and development

?

 

 

 

(11,184

)

 

Stock-based compensation

(7,353

)

 

 

(13,897

)

 

Depreciation and amortization

(1,413

)

 

 

(2,152

)

 

Non-GAAP operating expense

$

48,638

 

 

 

$

91,189

 

 

 

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, 2020

 

June 30, 2020

R&D expense:

 

 

 

GAAP R&D expense

$

27,103

 

 

 

$

66,897

 

 

Adjustments:

 

 

 

In-process research and development

?

 

 

 

(11,184

)

 

Stock-based compensation

(2,584

)

 

 

(5,026

)

 

Depreciation and amortization

(503

)

 

 

(1,000

)

 

Non-GAAP R&D expense

$

24,016

 

 

 

$

49,687

 

 

 


These press releases may also interest you

at 17:05
Sirona Biochem Corp. ("Sirona") announces the voting results from its Annual General Meeting of Shareholders (the "Meeting"), held in Vancouver, British Columbia on March 28, 2024. The total number of shares represented by shareholders present in...

at 17:00
The Doctors Company, the nation's largest physician-owned medical malpractice insurer, announced today that it has approved a 2024 premium dividend of approximately $14.7 million, bringing the total of declared dividends to date to $470 million....

at 17:00
Northern Virginia Oral, Maxillofacial & Implant Surgery ("NOVA OMS") has learned of a data security incident that may have impacted data belonging to certain patients and guarantors. On October 5, 2023, NOVA OMS became aware of unusual activity on...

at 17:00
The Journey Venture Studio announced today a strategic collaboration with Valleywise Health, a comprehensive healthcare system with locations throughout the Phoenix metro area. In pursuit of fostering innovation, this collaboration is set to...

at 16:32
The wishes that Make-A-Wish grants wouldn't be possible without the support of countless "WishMakers" such as donors, volunteers, corporate partners, community advocates and more. "WishMakers" ? a term for anyone who steps up to take action...

at 16:30
Today, the Honourable Ya'ara Saks, Minister of Mental Health and Addictions and Associate Minister of Health, announced a new appointment to the Canadian Centre on Substance Use and Addiction (CCSA) Board of Directors. Scott Elliott is appointed as...



News published on and distributed by: