false 0000025743 0000025743 2021-08-04 2021-08-04

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): August 4, 2021

 

TherapeuticsMD, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Nevada		001-00100		87-0233535
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

951 Yamato Road, Suite 220 Boca Raton, FL 33431

(Address of Principal Executive Office) (Zip Code)

 

Registrant’s telephone number, including area code:  (561) 961-1900

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common Stock, par value $0.001 per share	TXMD	The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230-405) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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Item 2.02

Results of Operations and Financial Condition.

 

Item 7.01

Regulation FD Disclosure.

 

The following information is provided pursuant to Item 7.01 of Form 8-K, “Regulation FD Disclosure” and Item 2.02 of Form 8-K, “Results of Operations and Financial Condition.”

 

On August 4, 2021, TherapeuticsMD, Inc. (the "Company") issued a press release announcing its financial results for the second quarter ended June 30, 2021.  In addition, the Company will be using a slide presentation during its earnings conference call.  Copies of the press release and slide presentation are furnished as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

 

This information and the information contained in Exhibits 99.1 and 99.2 is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in any such filing, regardless of any general incorporation language in the filing.

 

The Company does not have, and expressly disclaims, any obligation to release publicly any updates or any changes in its expectations or any change in events, conditions, or circumstances on which any forward-looking statement is based.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)	Exhibits
		Exhibit Index
	Exhibit No.	Description
	99.1	Press Release from TherapeuticsMD, Inc., dated August 4, 2021, entitled "TherapeuticsMD Announces Second Quarter 2021 Financial Results."
	99.2	TherapeuticsMD, Inc. Presentation dated August 4, 2021.
	104	Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document).

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date:  August 4, 2021		THERAPEUTICSMD, INC.
		/s/ James C. D’Arecca
		James C. D’Arecca
		Chief Financial Officer

 

 

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

TherapeuticsMD Announces Second Quarter 2021 Financial Results

 

- 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 4, 2021 – 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

 

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)

 

IMVEXXY (estradiol vaginal inserts)

 

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BIJUVA (estradiol and progesterone)

 

Cost of Goods Sold and Gross Margin

 

Operating Expense, Net Loss and Related Information

 

Balance Sheet

 

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.

 

 

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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 -

 

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TherapeuticsMD, Inc. and Subsidiaries

Consolidated Balance Sheets

(In thousands, except per share data)

 

 

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TherapeuticsMD, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited - in thousands, except per share data)

 

 

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TherapeuticsMD, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

(Unaudited - in thousands)

 

 

CONTACT:

Edward J. Borkowski

Executive Vice President

561-961-1900

 

Lisa M. Wilson

In-Site Communications, Inc.

212-452-2793

lwilson@insitecony.com

Building the Premier Women’s Health Company 2Q 2021 Earnings August 4, 2021 Exhibit 99.2

Forward-Looking Statements FOR INVESTOR PRESENTATION PURPOSES ONLY. 2

Summary of Q2 Performance FOR INVESTOR PRESENTATION PURPOSES ONLY. 3 Overall Revenue and Unit Growth Quarter over Quarter while Navigating Covid-19 OVERALL Revenue increase of 17% 2Q21 vs 1Q21 ANNOVERA 17% TRX Growth QoQ with number of providers writing slightly increasing, as well as average units per prescriber increasing Stable Net Revenue/Unit at $1,157 Positioning of ANNOVERA as the only long-lasting, procedure-free product is driving uptake MENOPAUSE PRODUCTS TRX growth QoQ for both IMVEXXY (8%) and BIJUVA (3.5%), while simultaneously increasing net revenue/unit for the menopause products Highest net revenue per unit for IMVEXXY at $64 BIJUVA 0.5/100 filing accepted with PDUFA date of March 21, 2022 Seven new European country approvals for BIJUVA VITACARE PRESCRIPTION SERVICES Two customers live, plus one new customer signed Strong pipeline that has grown to over 30 potential customers Continue to build foundation to become free-standing entity in a rapidly growing sector with no clear market leader

2Q21 Financial Overview FOR INVESTOR PRESENTATION PURPOSES ONLY. 4

$23.0 Quarterly Net Product Revenue $8 $6 $4 $2 $0 FOR INVESTOR PRESENTATION PURPOSES ONLY. 5 $14 $12 $10 $16 $24 $22 $20 $18 2Q 20 1Q 21 2Q 21 Quarterly Net Revenue Trends Millions 2Q21 Highlights Total net product revenue increased 17% 2Q21 vs 1Q21 Total net product revenue increased 115% 2Q21 vs 2Q20 Net revenue per unit for ANNOVERA remained steady at $1,157 per unit(1) IMVEXXY net revenue per unit continued to increase, achieving $64 for 2Q21(1) BIJUVA net revenue per unit remained steady at $68 for 2Q21(1) (1) Average net revenue per unit calculated based on units sold to wholesalers and pharmacies divided into net revenue for the quarter. $10.7 $19.6

Financial Results: Comparison 2Q 2021 to 1Q 2021 and 2Q 2020 Net product revenue of $23.0M was an increase of $12.3M compared to 2Q20 Gross margin of 82% increased from 59% in 2Q20 - Mainly attributable to 2Q20 margins being negatively impacted by inventory charges Higher operating expenses in 2Q21 reflect increased selling and marketing activities Net loss decreased by $9.3M from 2Q20 to $42.7M Net cash used in operating activities decreased to $26.5M 2 Q21 1 Q21 2 Q20 Balance Sheet(1) Income Statement Statement of Cash Flow Net Cash Used In Operating Activities ($26,532) ($38,380) ($55,954) (1) Balance Sheet as of quarter end. Comparison of Key Financial Statement Items [in 1,000’s] FOR INVESTOR PRESENTATION PURPOSES ONLY. 6

FOR INVESTOR PRESENTATION PURPOSES ONLY. 7 ANNOVERA: Unique Opportunity to Create a New Segment within Birth Control

Source: Prescription data per Symphony Health PHAST Data. (1) Average net revenue per unit calculated based on units sold to wholesalers and pharmacies divided into net revenue for the quarter. CONFIDENTIAL ANNOVERA Quarterly TRx 2,361 8 2,410 5,160 5,950 6,239 7,299 2,000 3,000 4,000 5,000 6,000 7,000 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 ANNOVERA TRX: Continued Growth Quarter over Quarter 2Q21 Key Metrics 202% YoY and 17% QoQ TRX growth Net revenue per unit stable at $1,157(1) Refill rates remain steady at ~50% Growth Drivers Growing access to our most important prescribers In Q221 sales representatives reached over 50% of our most important targets with live calls Increasing reach and frequency to most important targets is delivering higher pull through of ANNOVERA prescriptions Growth across all channels with continued faster growth for telemedicine (+26% 2Q21 vs 1Q21)

ANNOVERA Writers Steady with Depth of Writing Continuing to Grow Despite COVID-19, new prescribers increased slightly to ~3,200 Average number of prescriptions per prescriber increased 10% from 2 in Q1 to 2.2 in Q2 ~8,000 prescribers have written at least one prescription of ANNOVERA to date Writer base driven by both in person sales calls and non-personal promotion from marketing Key Takeaways 523 1,134 1,109 2,271 2,697 3,160 3,206 1,090 2,362 2,410 5,160 5,950 6,239 7,299 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 Q419 Q120 Q220 Q320 Q420 Q121 Q221 Number of Prescribers Units of ANNOVERA FOR INVESTOR PRESENTATION PURPOSES ONLY. 9

ANNOVERA Creating a New Procedure Free Long-Acting Segment New messaging focuses on long-acting procedure free alternative to IUD is attracting previous IUD users The majority of ANNOVERA patients are new to rings FOR INVESTOR PRESENTATION PURPOSES ONLY. 10 Source: vitaCare patient survey data. Q4 2020 N=102 YTD 2021 N=484

FOR INVESTOR PRESENTATION PURPOSES ONLY. 11 ANNOVERA Near Term Potential Growth Catalysts Environment Payor Provider Consumer 57% of Unrestricted Coverage CMS recommended in May that ANNOVERA receive its own unique J-Code with potential approval as early as the 4th quarter Medi-Cal Managed Medicaid approval slated for January 2022 Increased access to top providers with opening of country Expansion of non-personal promotion to primary care Continued focus on the growing telemedicine channel Continued partnership with Whitney Cummings to her ~1.3M followers Peer to Peer influencer program launched in July to ~1.9M million followers ACA being upheld Language in house appropriations supporting birth control choice Coalition formed to support access to contraception

FOR INVESTOR PRESENTATION PURPOSES ONLY. 12 IMVEXXY: Fastest Growing Branded Product in Vulvar and Vaginal Atrophy Category

FOR INVESTOR PRESENTATION PURPOSES ONLY. IMVEXXY Performance Drivers Source: Prescription data per Symphony Health PHAST Data. Thousands 108 117 100 105 110 115 120 1Q21 2Q21 TRx 13 IMVEXXY Quarterly Performance 2Q21 Key Metrics IMVEXXY TRX outpaced the VVA market with TRX increasing 8% 2Q21 vs 1Q21 Net revenue per unit improved to $64 4th quarter in a row growing net revenue per unit for IMVEXXY ~2% increase in prescribers writing a prescription in 2Q21 compared to 1Q21 (~14 vs ~13.7) Growth Drivers In Q2 sales representatives continued to improve live call reach to over 50% of our most important targets Prescriber base increased 2% 2Q21 vs 1Q21 Refill rates remain above the category average with ~4.4 fills per patient annually

$44 $41 $51 $54 $61 $40 $45 $50 $55 $60 $65 $70 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 IMVEXXY Net Price Per Unit Build Shows Improvement Post Cash Pay Change previous “calculated net revenue per unit” which used units sold to patients in the quarter. FOR INVESTOR PRESENTATION PURPOSES ONLY. 14 Jan 1st Cash Pay Changed to $75 1 Average net revenue per unit calculated based on units sold to wholesalers and pharmacies divided into net revenue for the quarter. Effective 1Q20, this reflects a change in methodology from (1) 56% improvement in net price per unit for 2Q21 compared to 2Q20 5% improvement in net price per unit for 2Q21 compared to 1Q21 $64

FOR INVESTOR PRESENTATION PURPOSES ONLY. 15 IMVEXXY Near Term Potential Growth Catalysts 61% commercial coverage with 8 of 9 top commercial plans secured Top 5 payor that has IMVEXXY as the only preferred branded product Q221 was highest net revenue per unit $75 Cash Pay program available Opportunity for increased access to top providers with opening of country Non-Personal promotion to supplement salesforce efforts to top VVA writers Recent launch of new telemedicine provider for increased access to IMVEXXY for women New DTC campaign “Long May she Reign” launched end of April and delivering above benchmarks for interest and engagement Payor Provider Consumer

FOR INVESTOR PRESENTATION PURPOSES ONLY. BIJUVA: First and Only FDA-Approved Bio-Identical Solution in Vasomotor Symptoms (VMS) Market 16

Thousands Source: Symphony Data Source: Prescription data per Symphony Health PHAST Data. 30.8 31.9 25 27 29 31 33 1Q21 2Q21 TRx BIJUVA Quarterly Performance BIJUVA Volume Increased YoY with Limited Focus BIJUVA 2Q21 Key Metrics BIJUVA TRX increased 3.5% 2Q21 vs 1Q21 ~4% increase in prescribers writing a prescription in 2Q21 compared to 1Q21 (~5.1K vs ~4.9K) Net revenue per unit remained steady at $68 Growth Drivers FOR INVESTOR PRESENTATION PURPOSES ONLY. 17 Sampling and merchandising effort throughout the salesforce has resumed BIJUVA 0.5/100 Filing accepted with PDUFA of March 21, 2022

Key Takeaways FOR INVESTOR PRESENTATION PURPOSES ONLY. 18 Strong quarter for the portfolio with 115% revenue growth 2Q21 vs 2Q20 and sequential quarter growth of 17% Cash used in operating activities decreased to $26.5MM Expect accelerated prescription trend to continue due to improved access online and in person Positive growth trends for ANNOVERA in every channel IMVEXXY achieved record net revenue per unit for the 4th quarter in a row PDUFA for BIJUVA low-dose March 21, 2022 Multiple BIJUVA approvals across Europe vitaCare continues to build foundation to become free-standing entity in a rapidly growing sector with no clear market leader Continue to evaluate investment into vitaCare including potentially selling a minority stake in vitaCare, which could provide non-dilutive funding to the company

19 Simplifies the process for obtaining a prescription, improving continuity of care and better patient outcomes Allows for visibility over the patient experience Provides transparency and detailed data insights FOR INVESTOR PRESENTATION PURPOSES ONLY.

FOR INVESTOR PRESENTATION PURPOSES ONLY. Q&A 20

21 FOR INVESTOR PRESENTATION PURPOSES ONLY. Appendix

FOR INVESTOR PRESENTATION PURPOSES ONLY. Prescription vitamins: $2.4 Prescription vitamins: $1.4 Prescription vitamins $1.4 IMVEXXY: $5.1 IMVEXXY: $7.0 IMVEXXY: $9.8 BIJUVA: $1.4 BIJUVA: $2.4 BIJUVA: $2.2 ANNOVERA: $1.8 ANNOVERA: $8.8 ANNOVERA: $9.6 $0 $2 $10 $8 $6 $4 $18 $16 $14 $12 $24 $22 $20 2Q 20 1Q 21 2Q 21 Quarterly Net Revenue Trends Millions 2Q21 Highlights Total net product revenue increased 115% 2Q21 vs 2Q20 ANNOVERA net revenue increased 421% IMVEXXY net revenue increased 93% Average net revenue per unit $64(1) BIJUVA net revenue increased 59% Average net revenue per unit $68(1) $23.0 Quarterly Net Product Revenue 22 Total net product revenue may not add due to rounding. (1) Average net revenue per unit calculated based on units sold to wholesalers and pharmacies divided into net revenue for the quarter. $10.7 $19.6

NRx Trend of Recently Launched Mass Market Product Volumes FOR INVESTOR PRESENTATION PURPOSES ONLY. 23 Symphony Health National Level Data. All trademarks are property of their respective owners. COVID’s impact on recently launched brands

Payor Status and Update Source: MMIT as of July 1st 2021. Note: (1) 66% covered with prior authorization (PA) / step edit; UR=unrestricted. (2) ANNOVERA Medicaid Note: estimated coverage will increase from 46% in July to ~56% on when MediCal controls all the Medicaid Managed Care formularies in California. Access Summary: Annovera: 6 of 9 top Commercial plans secured Medi-Cal expansion in January 2022 Recommended for J-Code approval by CMS to be implemented as early as Q421 FOR INVESTOR PRESENTATION PURPOSES ONLY. 24

Payor Progress: Maintained All Major Commercial Payors Source: MMIT as of July 1st 2021. Note: (1) Includes lives with PA to indication only. UR=unrestricted. FOR INVESTOR PRESENTATION PURPOSES ONLY. 25 Access Summary: IMVEXXY Have 8 or the 9 top Commercial plans Preferred Contract with one top 5 Payor

PROVIDERS EXPECT TO WRITE MORE RINGS, likely due to ANNOVERA’s unique properties Provider AWARENESS OF ANNOVERA HIGHER than other new birth control products in the market now at 79% Recognition is Growing of ANNOVERA’s Unique Position in the Marketplace Annovera is being seen as a Long-Acting Option which is driving intent to write more Rings ANNOVERA is GROWING in association as the ALTERNATIVE TO LARCS 79% ANNOVERA - Q2’21 Aided Familiarity with RX Birth Control Brands 28% 20% Vaginal Rings Q4'20 Vaginal Rings Q2'21 Anticipated Increase In Recommending / Prescribing Behavior For Birth Control 15% ANNOVERA Q4'20 ANNOVERA Q2'21 Brand Perception Of ‘Long-Lasting’ (Top 2 Box) 27% Source: HCP ATU June 2021 (N=150) CONFIDENTIAL 26