TherapeuticsMD Announces Second Quarter 2021 Financial Results

·13 min read

- 2Q21 total net product revenue increased by 17% over 1Q21 to $23 million -

- ANNOVERA® prescription growth supported by improved access to providers and increased telemedicine options for patients -

- Prescriptions for IMVEXXY® grew by 8% over 1Q21, outpacing the VVA market -

- Centers for Medicare and Medicaid Services recommended that ANNOVERA receive its own unique national J-Code that could be live as early as Q421 -

- vitaCare signed new customer and pipeline continues to grow -

- Conference call scheduled for 8:30 a.m. ET today -

BOCA RATON, Fla., August 04, 2021--(BUSINESS WIRE)--TherapeuticsMD, Inc. ("TXMD" or the "Company") (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the second quarter ended June 30, 2021.

"We continue to make steady progress in line with our expectations related to ANNOVERA and IMVEXXY driving prescription growth, net margins and broader patient access. Importantly, we are seeing improved access to health care providers for our sales force and expansion of our relationships in the telemedicine channel and believe we are well positioned to grow our products across all channels. Our overall volumes and net revenues were very healthy, and vitaCare prescription services is building the foundation for growth in the future. vitaCare recently signed its third customer contract and has a strong pipeline of more than 30 potential customers. In addition, we continue to evaluate investment into vitaCare, including potentially selling a minority stake, which could provide a non-dilutive source of capital for TXMD shareholders," said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD.

Second Quarter 2021 Financial Results and Business Highlights

Net Product Revenue

Three Months Ended

June 30,

March 31,

2021

2020

2021

ANNOVERA

$

9,555

$

1,835

$

8,750

IMVEXXY

9,838

5,086

7,012

BIJUVA

2,156

1,352

2,445

Prescription vitamin

1,452

2,428

1,425

Product revenue, net

23,001

10,701

19,632

License revenue

234

Total revenue, net

$

23,001

$

10,701

$

19,866

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)

  • ANNOVERA net product revenue of $9.6 million for the second quarter of 2021 increased by $7.7 million compared to $1.8 million for the second quarter of 2020 and $0.8 million compared to $8.8 million for the first quarter of 2021.

  • Net revenue per unit, calculated from sales to wholesalers and pharmacies, was $1,157 for the second quarter of 2021.

  • Approximately 7,299 ANNOVERA prescriptions were dispensed to patients during the second quarter of 2021. Prescriptions increased 202% compared to the second quarter of 2020 and 17% compared to the first quarter of 2021. Refill rates remained strong at approximately 50% for eligible patients.

IMVEXXY (estradiol vaginal inserts)

  • IMVEXXY net product revenue of $9.8 million for the second quarter of 2021 increased by $4.8 million compared to $5.1 million for the second quarter of 2020 and $2.8 million compared to $7.0 million for the first quarter of 2021.

  • Net revenue per unit, calculated from sales to wholesalers and pharmacies, was $64 for the second quarter of 2021, reflecting a 56% improvement in net price compared to the second quarter of 2020. This is the fourth consecutive quarter that IMVEXXY has achieved a record net revenue per unit.

  • Approximately 117,000 IMVEXXY prescriptions were dispensed to patients during the second quarter of 2021. Total prescriptions increased by 8% from the first quarter of 2021. IMVEXXY fill rates remained above category averages at approximately 4.4 fills per year with over 20% of patients filling a 90-day supply.

  • New telemedicine relationship with UpScript is designed to provide increased patient access to IMVEXXY with the potential to improve conversion to prescription in the online channel.

  • The recently launched direct-to-consumer campaign for IMVEXXY, Long May She Reign, has had a positive impact on both interest and engagement.

BIJUVA (estradiol and progesterone)

  • BIJUVA net product revenue of $2.2 million for the second quarter of 2021 increased by $0.8 million compared to $1.4 million for the second quarter of 2020 but decreased by $0.3 million compared to $2.4 million for the first quarter of 2021.

  • Net revenue per unit, calculated from sales to wholesalers and pharmacies, was approximately $68 for the second quarter of 2021.

  • Approximately 31,900 BIJUVA prescriptions were dispensed to patients in the second quarter of 2021. Total prescriptions increased by 3.5% from the first quarter of 2021.

  • BIJUVA received approval in seven European countries.

  • BIJUVA 0.5/100 received a PDUFA date of March 21, 2022.

Cost of Goods Sold and Gross Margin

  • Cost of goods was $4.1 million with gross margin of 82% for the second quarter of 2021 compared to $4.4 million with gross margin of 59% for the second quarter of 2020 and $4.7 million with gross margin of 76% for the first quarter of 2021. The improvement in the Company’s gross margin for the second quarter of 2021 from the second quarter of 2020 and first quarter of 2021 was mainly attributable to an inventory obsolescence charge in the second quarter of 2020 and the first quarter of 2021.

Operating Expense, Net Loss and Related Information

  • Total operating expense of $54.0 million for the second quarter of 2021 increased by $2.7 million compared to $51.3 million for the second quarter of 2020 and $9.6 million compared to $44.5 million for the first quarter of 2021.

  • Net loss for the second quarter of 2021 was $42.7 million, or $0.11 per basic and diluted share, compared to net loss for the second quarter of 2020 of $52.0 million, or $0.19 per basic and diluted share, and net loss for the first quarter of 2021 of $39.4 million, or $0.11 per basic and diluted share.

Balance Sheet

  • As of June 30, 2021, the Company’s cash on hand totaled $111.4 million, compared with $80.5 million as of December 31, 2020.

  • For the first six months of 2021, the Company received $151.1 million in net proceeds from its at-the-market and underwritten equity offerings. Subsequent to quarter-end, in July 2021, the Company received an additional $31.8 million in net proceeds from its at-the-market offering.

  • As of June 30, 2021, the remaining outstanding principal amount under the Company’s Financing Agreement was $200.0 million, which reflects a repayment of $50.0 million of principal during the first six months of 2021.

Conference Call and Webcast Details

TherapeuticsMD will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss these financial results and provide a business update.

Date:

Wednesday, August 4, 2021

Time:

8:30 a.m. ET

Telephone Access (US):

866-665-9531

Telephone Access (International):

724-987-6977

Access Code for All Callers:

7736027

A live webcast and audio archive for the event may be accessed on the home page or from the "Investors & Media" section of the TherapeuticsMD website at www.therapeuticsmd.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least 30 days. In addition, a digital recording of the conference call will be available for replay beginning two hours after the call's completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 7736027.

Please see the Full Prescribing Information, including indication and Boxed WARNING, for each TherapeuticsMD product as follows:

Forward-Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest, or obtain an investment in, its vitaCare business and how the proceeds that may be generated by any such divestiture or investment will be utilized; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

- Financial Statements to Follow -

TherapeuticsMD, Inc. and Subsidiaries

Consolidated Balance Sheets

(In thousands, except per share data)

June 30, 2021

December 31, 2020

(Unaudited)

Assets:

Current assets:

Cash

$

111,424

$

80,486

Accounts receivable, net of allowance for credit losses of $1,273 and $1,118 as of June 30, 2021 and December 31, 2020, respectively

33,481

32,382

Inventory

7,574

7,993

Prepaid and other current assets

7,178

7,543

Total current assets

159,657

128,404

Fixed assets, net

1,647

1,942

License rights and other intangible assets, net

40,206

41,445

Right of use assets

8,838

9,566

Other non-current assets

253

253

Total assets

$

210,601

$

181,610

Liabilities and stockholders' equity (deficit):

Current liabilities:

Current maturities of long-term debt

$

10,000

$

Accounts payable

14,565

21,068

Accrued expenses and other current liabilities

51,110

38,170

Total current liabilities

75,675

59,238

Long-term debt, net

175,261

237,698

Operating lease liabilities

8,381

8,675

Other non-current liabilities

358

Total liabilities

259,675

305,611

Commitments and contingencies

Stockholders' equity (deficit):

Preferred stock, par value $0.001; 10,000 shares authorized, none issued

Common stock, par value $0.001; 600,000 shares authorized, 395,048 and 299,765 issued and outstanding as of June 30, 2021 and December 31, 2020, respectively

395

300

Additional paid-in capital

911,511

754,644

Accumulated deficit

(960,980

)

(878,945

)

Total stockholders' deficit

(49,074

)

(124,001

)

Total liabilities and stockholders' equity (deficit)

$

210,601

$

181,610

TherapeuticsMD, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited - in thousands, except per share data)

Three Months Ended

Six Months Ended

June 30,

March 31,

June 30,

2021

2020

2021

2021

2020

Product revenue, net

$

23,001

$

10,701

$

19,632

$

42,633

$

22,952

License revenue

234

234

Total revenue, net

23,001

10,701

19,866

42,867

22,952

Cost of goods sold

4,132

4,400

4,687

8,819

7,115

Gross profit

18,869

6,301

15,179

34,048

15,837

Operating expenses:

Selling and marketing

32,164

29,887

24,024

56,188

68,683

General and administrative

19,873

18,710

18,383

38,256

37,103

Research and development

2,011

2,742

2,050

4,061

6,011

Total operating expenses

54,048

51,339

44,457

98,505

111,797

Loss from operations

(35,179

)

(45,038

)

(29,278

)

(64,457

)

(95,960

)

Other (expense) income:

Interest expense and other financing costs

(7,596

)

(7,027

)

(10,227

)

(17,823

)

(13,289

)

Other income, net

123

89

122

245

424

Total other (expense), net

(7,473

)

(6,938

)

(10,105

)

(17,578

)

(12,865

)

Loss before income taxes

(42,652

)

(51,976

)

(39,383

)

(82,035

)

(108,825

)

Provision for income taxes

Net loss

$

(42,652

)

$

(51,976

)

$

(39,383

)

$

(82,035

)

$

(108,825

)

Loss per common share, basic and diluted

$

(0.11

)

$

(0.19

)

$

(0.11

)

$

(0.22

)

$

(0.40

)

Weighted average common shares, basic and diluted

394,074

271,876

347,219

370,776

271,668

TherapeuticsMD, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

(Unaudited - in thousands)

Six Months Ended June 30,

2021

2020

Cash flows from operating activities:

Net loss

$

(82,035

)

$

(108,825

)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

2,061

2,019

Charges (credits) to provision for doubtful accounts

445

(182

)

Inventory charge

502

5,965

Debt financing fees

2,681

692

Non-cash operating lease expense, including impairment of $81 for the six months ended June 30, 2020

434

770

Share-based compensation

5,467

5,369

Changes in operating assets and liabilities:

Accounts receivable

(1,544

)

6,287

Inventory

(83

)

(4,277

)

Prepaid and other current assets

365

4,448

Accounts payable

(6,503

)

(1,911

)

Accrued expenses and other current liabilities

12,940

(5,420

)

Other non-current liabilities

358

Total adjustments

17,123

13,760

Net cash used in operating activities

(64,912

)

(95,065

)

Cash flows from investing activities:

Payment of patent related costs

(423

)

(816

)

Purchase of fixed assets

(104

)

(26

)

Net cash used in investing activities

(527

)

(842

)

Cash flows from financing activities:

Proceeds from sale of common stock, net of costs

151,062

Proceeds from exercise of options and warrants

299

166

Proceeds from sale of common stock related to employee stock purchase plan

134

Repayments of debt

(50,000

)

Borrowings of debt

50,000

Payment of debt financing fees

(5,118

)

(1,250

)

Net cash provided by financing activities

96,377

48,916

Net increase in cash

30,938

(46,991

)

Cash, beginning of period

80,486

160,830

Cash, end of period

$

111,424

$

113,839

Supplemental disclosure of cash flow information:

Interest paid

$

14,284

$

12,032

View source version on businesswire.com: https://www.businesswire.com/news/home/20210804005316/en/

Contacts

Edward J. Borkowski
Executive Vice President
561-961-1900

Lisa M. Wilson
In-Site Communications, Inc.
212-452-2793
lwilson@insitecony.com

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