UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE
ACT OF 1934
Date of Report
(Date of earliest event reported):
(Exact Name of Registrant as Specified in its Charter)
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including area code:
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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) | |
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| 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:
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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. ☐
| Item 2.02 | Results of Operations and Financial Condition. |
On August 6, 2020, TherapeuticsMD, Inc. (the "Company") issued a press release announcing its financial results for the second quarter ended June 30, 2020. In addition, the Company will be using a slide presentation during its earnings conference call. A copy 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.
The information in Item 2.02 of this Current Report on Form 8-K (including the exhibits) is furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in Item 2.02 of this Current Report on Form 8-K (including the exhibits) shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date of this Current Report, 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 7.01 | Regulation FD Disclosure. |
On August 6, 2020, the Company issued a press release announcing the Company’s financial results for its second quarter ended June 30, 2020. In addition, the Company will be using a slide presentation during its earnings conference call. The information included in this Item 7.01 and in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
Exhibit Index
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Exhibit Number |
Description | |
99.1 |
| |
| 99.2 | TherapeuticsMD, Inc. Presentation dated August 6, 2020.
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| 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 6, 2020 | THERAPEUTICSMD, INC. | |
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| By: | /s/ James C. D'Arecca | |
| Name: | James C. D'Arecca | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
FOR IMMEDIATE RELEASE
TherapeuticsMD® Announces Second Quarter 2020 Financial Results
- 2Q20 total net product revenue of $10.7 million resilient despite COVID-19 pandemic -
- ANNOVERA® prescriptions increased approximately 100% for the eight weeks ended July 24, 2020 over the previous eight week period-
- IMVEXXY® new prescriptions increased 33% for the eight weeks ended July 24, 2020 over the previous eight week period-
- Consumer campaign for ANNOVERA achieved over 3 million unique views in first 30 days -
- Initial consumer marketing campaign for IMVEXXY to be launched in August -
- Amended Sixth Street Partners revenue covenants to reflect impact of COVID-19 pandemic -
- Conference call scheduled for 8:30 a.m. ET today -
BOCA RATON, Fla. – August 6, 2020 – TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the second quarter ended June 30, 2020.
“Our organization made significant progress in the second quarter while navigating the COVID-19 pandemic and its impact on our business,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. “We delivered a strong quarter of operational execution during very unique circumstances, quickly reducing our operating expenses, reorienting our sales force, and addressing our credit facility future minimum net revenue covenants. These strategic and operational changes and our reshaped Board of Directors and management team are focused on driving revenue and achieving our goal of reaching EBITDA break even in 2021, which we believe will result in long-term shareholder value.”
Recent Updates
| ● | Prescription volume for ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) for the eight weeks ended July 24, 2020 increased approximately 100% over the previous eight weeks (the time period most heavily impacted by COVID-19). ANNOVERA current prescription trend exceeds the product’s pre-COVID-19 launch trajectory. |
| ● | The Company initiated the direct-to-consumer marketing campaign for ANNOVERA on July 1, 2020. Digital metrics show that the “Unapologetically ANNOVERA” campaign has quickly gained visibility resulting in over 100 million impressions and 3 million unique views since launch. |
| ● | The Company is working with the Department of Defense, public health organizations, and telehealth platforms to expand access to women and contribute to the Company’s growth in the second half of the year. |
| ● | As of July 1, 2020, ANNOVERA achieved 79% commercial coverage and 46% Medicaid coverage. The vast majority of patients are covered without a copay. |
| ● | IMVEXXY (estradiol vaginal inserts) new prescriptions for the eight weeks ended July 24, 2020 increased 33% over the previous eight weeks ended May 29, 2020 (the time period most heavily impacted by COVID-19). IMVEXXY continues to experience strong refill rates. These trends should positively impact total prescriptions going forward. |
| ● | The Company plans to launch the consumer marketing campaign for IMVEXXY during August 2020. |
| ● | IMVEXXY’s commercial market access is 72% unrestricted commercial coverage, including all of the top ten commercial payors of VVA products. The Company added Wellcare as a Medicare Part D payor. |
| ● | As of July 1, 2020, BIJUVA® (estradiol and progesterone) capsules commercial market access increased to 73% unrestricted commercial coverage with nine of the top ten commercial payors. |
Sixth Street Update
| ● | The Company worked with Sixth Street Partners (“Sixth Street”) to adjust the total minimum net revenue covenant in its financing agreement to reflect the impact of COVID-19. The covenants begin with the results for the fourth quarter of 2020. |
| ● | The total minimum net revenue requirement for ANNOVERA, IMVEXXY, and BIJUVA was adjusted to $20 million for the fourth quarter of 2020. In 2021, the minimum net revenue covenant will be $25 million, $37.5 million, $47.5 million, and $57.5 million for the first, second, third, and fourth quarters, respectively. Given the Company’s current rate of growth, the Company believes it is well positioned to meet or exceed these minimum covenants. |
| ● | The Company and Sixth Street are not moving forward with the undrawn $50 million tranche under the financing agreement, which was designed to be drawn following the successful full commercial launch of ANNOVERA in the second quarter, due to the pause in the launch timing caused by the COVID-19 pandemic. There continues to be an active dialogue with Sixth Street regarding potential additional financing. |
Second Quarter Highlights
| ● | Net product revenue for the second quarter of 2020 was $10.7 million. |
| ● | The COVID-19 pandemic had a significant impact on the Company’s product revenue early in the second quarter of 2020. The Company’s products returned to growth mid to late quarter. Notwithstanding COVID-19, the Company expects continued growth in the second half of 2020. |
| ● | In the second quarter 2020, ANNOVERA net revenue was $1.8 million. Approximately 2,400 ANNOVERA prescriptions were dispensed. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was $1,332. |
| ● | In the second quarter 2020, IMVEXXY net revenue was $5.1 million. Approximately 118,000 IMVEXXY prescriptions were dispensed. Net revenue per unit was $41. Strong IMVEXXY refill rates continued with patients adhering to therapy. |
| ● | In the second quarter 2020, BIJUVA net revenue was $1.4 million. Approximately 27,600 BIJUVA prescriptions were dispensed. Net revenue per unit was $45 for the second quarter of 2020. |
Net Product Revenue
|
Three Months Ended June 30, 2020 |
Three Months Ended June 30, 2019 |
Three Months Ended March 31, 2020 |
|||||||||
| ANNOVERA | $ | 1,835,460 | $ | — | $ | 2,272,761 | |||||
| IMVEXXY | 5,085,190 | 3,121,711 | 6,392,601 | ||||||||
| BIJUVA | 1,352,001 | 134,282 | 1,111,604 | ||||||||
| Prenatal vitamins | 2,428,382 | 2,822,872 | 2,473,691 | ||||||||
| Net revenue | $ | 10,701,033 | $ | 6,078,865 | $ | 12,250,657 | |||||
Net product revenue for the second quarter of 2020 was affected by the COVID-19 pandemic across all of our products.
Cost of Goods Sold/Gross Margin
Cost of goods sold increased $1.7 million for the second quarter of 2020 compared to the first quarter of 2020, as the result of a non-cash write-off of $1.9 million primarily related to BIJUVA inventory obsolescence, partially offset by the impact of an overall decline in unit sales. The charge is the result of the Company’s reprioritization of selling resources to ANNOVERA and IMVEXXY along with the impact of the COVID-19 pandemic on sales forecasts of BIJUVA for future quarters. This charge caused gross margin percentage to decline from 78% for the quarter ended March 31, 2020 to 59% for the quarter ended June 30, 2020.
Expense, EPS and Related Information
Total operating expenses decreased by $9.2 million to $51.3 million for the second quarter of 2020 as compared to $60.5 million for the first quarter of 2020. The decrease in operating expenses was primarily a result of the Company’s cost containment and spend-rebalancing efforts to reduce overall spend in the remaining quarters of the 2020 fiscal year. For the remainder of 2020, spend will focus on delivering the necessary resources to support the launch of ANNOVERA, continued ramp-up of IMVEXXY, and ongoing brand management of BIJUVA. The second quarter of 2020 was impacted by $3.9 million in charges related to product samples expense as a result of the Company’s decision to reduce sampling of BIJUVA.
Net loss for the quarter ended June 30, 2020 decreased to $52.0 million, or $0.19 per basic and diluted share, compared with $56.8 million, or $0.21 per basic and diluted share, for the quarter ended March 31, 2020. Net loss per share for the second quarter of 2020 was impacted by inventory and sample expense charges related primarily to BIJUVA of $0.02 per basic and diluted share.
Balance Sheet
As of June 30, 2020, the Company’s cash on hand totaled $113.8 million, compared with $170.1 million on March 31, 2020. The decline in cash was due primarily to the net loss for the quarter ended June 30, 2020, less certain non-cash items, as well as the timing of advertising, marketing, and social media campaigns for ANNOVERA that were incurred at the end of the quarter ended March 31, 2020 and funded early in the quarter ended June 30, 2020. Total outstanding debt, net of issuance costs, was $243.8 million as of June 30, 2020, compared to $243.4 million as of March 31, 2020. The change is due to the amortization of debt discount of $400,000.
Sixth Street Additional Information
| ● | In connection with the adjustment to the Sixth Street total minimum net revenue covenant and in lieu of a cash amendment fee, the Company issued to the Sixth Street lenders warrants to purchase an aggregate of approximately 4.75 million shares of the Company’s common stock with an exercise price of $1.58 per share and a ten year term. The warrants are unregistered, do not have registration rights, and do not have anti-dilution protection, other than for customary stock splits and similar transactions. |
| ● | The total minimum net revenue requirement for ANNOVERA, IMVEXXY, and BIJUVA in 2022 will be $65 million, $75 million, $85 million, and $95 million for the first, second, third, and fourth quarters, respectively, and will remain at $95 million for subsequent quarters. |
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: | Thursday, August 6, 2020 |
| Time: | 8:30 a.m. ET |
| Telephone Access (US): | 866-665-9531 |
| Telephone Access (International): | 724-987-6977 |
| Access Code for All Callers: | 2963048 |
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: 2963048.
Please see the Full Prescribing Information, including indication and Boxed WARNING, for each TherapeuticsMD product as follows:
| ● | IMVEXXY (estradiol vaginal inserts) at https://imvexxy.com/pi.pdf |
| ● | BIJUVA (estradiol and progesterone) capsules at https://www.bijuva.com/pi.pdf |
| ● | ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf |
About TherapeuticsMD
TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The Company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.
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; 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 efficacy
supplement for 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. PDF copies of the company’s historical press releases and financial tables can be viewed
and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.
# # #
Investor Contact
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| June 30, 2020 | December 31, 2019 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 113,839,234 | $ | 160,829,713 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $722,240 and $904,040, respectively | 18,290,784 | 24,395,958 | ||||||
| Inventory, net | 10,172,312 | 11,860,716 | ||||||
| Other current assets | 6,641,587 | 11,329,793 | ||||||
| Total current assets | 148,943,917 | 208,416,180 | ||||||
| Fixed assets, net | 2,145,926 | 2,507,775 | ||||||
| Other Assets: | ||||||||
| License rights, net | 37,721,695 | 39,221,308 | ||||||
| Intangible assets, net | 5,942,873 | 5,258,211 | ||||||
| Right of use assets | 10,337,577 | 10,109,154 | ||||||
| Other assets | 446,925 | 473,009 | ||||||
| Total other assets | 54,449,070 | 55,061,682 | ||||||
| Total assets | $ | 205,538,913 | $ | 265,985,637 | ||||
| LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 17,270,319 | $ | 19,181,212 | ||||
| Other current liabilities | 29,213,411 | 33,823,613 | ||||||
| Total current liabilities | 46,483,730 | 53,004,825 | ||||||
| Long-Term Liabilities: | ||||||||
| Long-term debt | 243,801,705 | 194,634,643 | ||||||
| Operating lease liability | 9,307,361 | 9,145,049 | ||||||
| Other long-term liabilities | 35,000 | — | ||||||
| Total long-term liabilities | 253,144,066 | 203,779,692 | ||||||
| Total liabilities | 299,627,796 | 256,784,517 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders’ (Deficit) Equity: | ||||||||
| Preferred stock - par value $0.001; 10,000,000 shares authorized; | ||||||||
| no shares issued and outstanding | — | — | ||||||
| Common stock - par value $0.001; 600,000,000 and 350,000,000 shares authorized; 272,294,380 and 271,177,076 issued and outstanding, respectively | 272,294 | 271,177 | ||||||
| Additional paid-in capital | 709,885,568 | 704,351,222 | ||||||
| Accumulated deficit | (804,246,745 | ) | (695,421,279 | ) | ||||
| Total stockholders’ (deficit) equity | (94,088,883 | ) | 9,201,120 | |||||
| Total liabilities and stockholders’ equity | $ | 205,538,913 | $ | 265,985,637 | ||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended | Three Months Ended | Six Months Ended | ||||||||||||||||||
| June 30, | March 31, | June 30, | ||||||||||||||||||
| 2020 | 2019 | 2020 | 2020 | 2019 | ||||||||||||||||
| Product revenue, net | $ | 10,701,033 | $ | 6,078,865 | $ | 12,250,657 | $ | 22,951,690 | $ | 10,025,516 | ||||||||||
| Cost of goods sold | 4,400,485 | 1,248,860 | 2,715,051 | 7,115,536 | 2,011,687 | |||||||||||||||
| Gross profit | 6,300,548 | 4,830,005 | 9,535,606 | 15,836,154 | 8,013,829 | |||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Sales, general, and administrative | 48,340,628 | 41,387,451 | 56,927,021 | 105,267,649 | 76,251,533 | |||||||||||||||
| Research and development | 2,742,032 | 4,964,368 | 3,268,829 | 6,010,861 | 11,282,250 | |||||||||||||||
| Depreciation and amortization | 256,557 | 115,059 | 261,994 | 518,551 | 221,997 | |||||||||||||||
| Total operating expenses | 51,339,217 | 46,466,878 | 60,457,844 | 111,797,061 | 87,755,780 | |||||||||||||||
| Operating loss | (45,038,669 | ) | (41,636,873 | ) | (50,922,238 | ) | (95,960,907 | ) | (79,741,951 | ) | ||||||||||
| Other (expense) income | ||||||||||||||||||||
| Loss on extinguishment of debt | — | (10,057,632 | ) | — | — | (10,057,632 | ) | |||||||||||||
| Miscellaneous income | 88,858 | 486,597 | 335,482 | 424,340 | 1,175,318 | |||||||||||||||
| Interest expense | (7,026,853 | ) | (4,028,609 | ) | (6,262,046 | ) | (13,288,899 | ) | (6,118,627 | ) | ||||||||||
| Total other expense | (6,937,995 | ) | (13,599,644 | ) | (5,926,564 | ) | (12,864,559 | ) | (15,000,941 | ) | ||||||||||
| Loss before income taxes | (51,976,664 | ) | (55,236,517 | ) | (56,848,802 | ) | (108,825,466 | ) | (94,742,892 | ) | ||||||||||
| Provision for income taxes | — | — | — | — | — | |||||||||||||||
| Net loss | $ | (51,976,664 | ) | $ | (55,236,517 | ) | $ | (56,848,802 | ) | $ | (108,825,466 | ) | $ | (94,742,892 | ) | |||||
| Loss per share, basic and diluted: | ||||||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.19 | ) | $ | (0.23 | ) | $ | (0.21 | ) | $ | (0.40 | ) | $ | (0.39 | ) | |||||
| Weighted average number of common | ||||||||||||||||||||
| shares outstanding, basic and diluted | 271,876,238 | 241,221,840 | 271,459,522 | 271,667,879 | 241,114,532 | |||||||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| Six Months Ended | ||||||||
| June 30, | ||||||||
| 2020 | 2019 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (108,825,466 | ) | $ | (94,742,892 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation of fixed assets | 387,649 | 133,049 | ||||||
| Amortization of intangible assets | 130,902 | 88,948 | ||||||
| Write off of patent and trademark costs | — | 78,864 | ||||||
| Operating lease impairment | 81,309 | — | ||||||
| Non-cash operating lease expense | 689,089 | 443,734 | ||||||
| (Recovery of) provision for doubtful accounts | (181,800 | ) | 167,500 | |||||
| Inventory obsolesence reserve | 5,965,139 | — | ||||||
| Loss on extinguishment of debt | — | 10,057,632 | ||||||
| Share-based compensation | 5,369,279 | 5,224,212 | ||||||
| Amortization of deferred financing fees | 692,442 | 316,880 | ||||||
| Amortization of license fee | 1,499,613 | — | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 6,286,974 | (7,486,691 | ) | |||||
| Inventory | (4,276,735 | ) | (4,226,770 | ) | ||||
| Other current assets | 4,412,827 | 1,710,697 | ||||||
| Accounts payable | (1,910,893 | ) | (3,244,603 | ) | ||||
| Accrued expenses and other current liabilities | (5,420,628 | ) | 2,801,717 | |||||
| Net cash used in operating activities | (95,100,299 | ) | (88,677,723 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (815,564 | ) | (763,247 | ) | ||||
| Purchase of fixed assets | (25,800 | ) | (1,092,504 | ) | ||||
| Security deposit | 35,000 | (20,420 | ) | |||||
| Net cash used in investing activities | (806,364 | ) | (1,876,171 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from exercise of options and warrants | 166,184 | 100,107 | ||||||
| Repayment of the Credit Agreement | — | (81,660,719 | ) | |||||
| Proceeds from the Financing Agreement | 50,000,000 | 200,000,000 | ||||||
| Payment of deferred financing fees | (1,250,000 | ) | (6,652,270 | ) | ||||
| Net cash provided by financing activities | 48,916,184 | 111,787,118 | ||||||
| Increase (decrease) in cash | (46,990,479 | ) | 21,233,224 | |||||
| Cash, beginning of period | 160,829,713 | 161,613,077 | ||||||
| Cash, end of period | $ | 113,839,234 | $ | 182,846,301 | ||||
| Supplemental disclosure of cash flow information | ||||||||
| Interest paid | $ | 12,032,014 | $ | 6,989,570 | ||||
Exhibit 99.2
FOR INVESTOR PRESENTATION PURPOSES ONLY. 2Q 2020 Earnings August 6, 2020
FOR INVESTOR PRESENTATION PURPOSES ONLY. Forward - Looking Statements This presentation by TherapeuticsMD, Inc . (referred to as “we,” “our,” or “the Company”) may contain forward - looking statements . Forward - looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future . These statements are often characterized by terminology such as “believe,” “hope,” “may,” “anticipate,” “should,” “intend,” “plan,” “will,” “expect,” “estimate,” “project,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of our managerial experience and perception of historical trends, current conditions, expected future developments and other factors we believe to be appropriate . Forward - looking statements in this presentation are made as of the date of this presentation, and we undertake 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 may be outside of our 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 our filings with the Securities and Exchange Commission (SEC), including our most recent Annual Report on Form 10 - K and Quarterly Reports on Form 10 - Q, as well as our current reports on Form 8 - K, and include the following : the company’s ability to protect the intellectual property related to its products ; 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 ; 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 efficacy supplement for 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 . This non - promotional presentation is intended for investor audiences only . 2
FOR INVESTOR PRESENTATION PURPOSES ONLY. Strategic Overview 3
FOR INVESTOR PRESENTATION PURPOSES ONLY. Strategic Overview ▪ 2Q20 total net revenue was resilient despite COVID - 19 ▪ Set Sixth Street revenue covenants to reflect the impact of COVID - 19 ▪ Executed a strategic and multifaceted plan to adapt to the new reality of a global pandemic and drive long - term shareholder value ⎯ Swift action to right - size our company, reduction of total operating expenses expected to trend to ~$40M by 4Q20 ⎯ Remain laser focused on reaching goal of EBITDA breakeven on a quarterly basis in 2021 ⎯ Pivoted sales force to operate in a “hybrid” model and support healthcare providers virtually ⎯ Launched into new channels of distribution including telehealth, public health and Department of Defense to accelerate growth ⎯ Reshaped Board of Directors and Management Team ▪ Despite COVID - 19, the Company returned product portfolio to growth which is expected to continue throughout 2020 4
FOR INVESTOR PRESENTATION PURPOSES ONLY. Sixth Street Update 5
FOR INVESTOR PRESENTATION PURPOSES ONLY. Sixth Street Loan Update ▪ Revised total minimum net revenue covenants for ANNOVERA, IMVEXXY and BIJUVA ▪ While not formal guidance, covenants are based on the Company’s post - COVID - 19 revised forecast ▪ The Company and Sixth Street are not moving forward with the undrawn $50 million tranche under the financing agreement, which was designed to be drawn following the successful full commercial launch of ANNOVERA in the second quarter, due to the pause in the launch timing caused by the COVID - 19 pandemic ▪ There continues to be an active dialogue with Sixth Street regarding potential additional financing 4Q 2020 1Q 2021 2Q 2021 3Q 2021 4Q 2021 $20M $25M $37.5M $47.5M $57.5M 6
FOR INVESTOR PRESENTATION PURPOSES ONLY. Financial Update 7
FOR INVESTOR PRESENTATION PURPOSES ONLY. Quarterly Net Revenue Trends Quarterly Net Revenue ▪ 2Q20 total net revenue of $10.7M ▪ Early in the quarter, due to COVID - 19 there was a reduction in patient visits to healthcare providers that negatively impacted volumes ▪ L ater in the quarter, we saw patient demand for ANNOVERA outpace wholesaler orders resulting in a drawdown of inventory in the channel ▪ More recently, we are pleased to see early momentum building through commercial execution of our plans and expect this to continue throughout the rest of 2020 8
FOR INVESTOR PRESENTATION PURPOSES ONLY. 2Q20 Key Metrics 1 Average net revenue per unit calculated based on units sold to wholesalers and pharmacies divided into net revenue for the qu art er 2 Average net revenue per unit calculated based on units sold to wholesalers and pharmacies divided into net revenue for the qu art er. This reflects a change in methodology from previous “calculated net revenue per unit” which used units sold to patients in the quarter. ANNOVERA IMVEXXY BIJUVA Net Revenue ~$1.8M ~$5.1M ~$1.4M Average Net Revenue / Unit : ~$1,332 1 ~$41 2 ~$45 2 Overall adjudication rate : ~99% ~44% ~56% 9
FOR INVESTOR PRESENTATION PURPOSES ONLY. Financial Results: Comparison 2Q 2020 to 1Q 2020 1 E xcluding non - cash items; depending on performance additional investment in SG&A to further drive growth and enhance employee ret ention may be made. ▪ D e - emphasis of BIJUVA triggered write - offs ▪ $1.9M impact on cost of sales negatively impacted gross margin ▪ $3.9M one - time charge for write - off of BIJUVA samples ▪ Excluding the one - time charge of $3.9M for BIJUVA write - off of samples, total cash related operating expenses were $47.4M ▪ Expect total operating expenses to trend down to ~$40M in 4Q20 1 ▪ Net cash used in operating activities was impacted by ~$11M in accrued expenses incurred in the 1Q20 for the launch of ANNOVERA which were paid in the 2Q20 2Q 2020 1Q 2020 Balance Sheet Cash $113,839,234 $170,097,813 Working Capital $102,460,187 $150,349,000 Long - term Debt $243,801,705 $243,428,671 Income Statement Product Revenue, Net $10,701,033 $12,250,657 Gross Profit $6,300,548 $9,535,606 % of Gross Margin 59% 78% Total Operating Expenses $51,339,217 $60,457,844 Net Loss ($51,976,644) ($56,848,802) Statement of Cash Flow Net Cash Used In Operating Activities ($55,990,299) ($39,110,980) Comparison of Key Financial Statement Items 10
FOR INVESTOR PRESENTATION PURPOSES ONLY. Commercial Updates 11
FOR INVESTOR PRESENTATION PURPOSES ONLY. ▪ ANNOVERA commercial access is 79%* and the vast majority paying $0 copay ▪ Fee for Service Medicaid unrestricted in 37 states plus D.C. ▪ Added Wellcare as a Part D payor for IMVEXXY ▪ Added CVS and Anthem as commercial payors for BIJUVA; secured 9 of the top 10 commercial payors 2Q20 and Recent Payor Progress Coverage May 2020 Coverage July 2020 ANNOVERA Commercial 64% UR, 76% 66% UR, 79%* Medicaid 45% 46% Department of Defense On Formulary On Formulary IMVEXXY Commercial 72% 72% Part D 27% 37%^ BIJUVA Commercial 54% 73% 12 Source: + MMIT as of July 1st , 2020. *66% unrestricted, 79% covered with prior authorization (PA) / step edit. ^Includes lives with PA to indication only. UR=unrestricted.
FOR INVESTOR PRESENTATION PURPOSES ONLY. 2Q20 Key Performance Metrics: IMVEXXY Source : Symphony IMVEXXY 2Q 2020 TRx to patients ~118,000 # Prescribers w/ TRx ~12,000 Overall adjudication rate ~44% ▪ Focus on fills allows for continued revenue growth ▪ Average of 5 fills per patient since launch ▪ Since 4Q19 the VVA class, on a quarterly basis, declined 15%, largely due to COVID - 19 ▪ IMVEXXY modest market share growth vs 4 th quarter of 2019 ▪ IMVEXXY New RX increased 33% for 8 weeks ended 7/24/20 over previous 8 weeks setting us up for TRX growth in future months Data Source: Prescription data per Symphony Health PHAST Data through 7/24/2019 IMVEXXY Weekly NRx Thousands 1 1.5 2 2.5 3 3-Apr 10-Apr 17-Apr 24-Apr 1-May 8-May 15-May 22-May 29-May 5-Jun 12-Jun 19-Jun 26-Jun 3-Jul 10-Jul 17-Jul 24-Jul 13 33% growth 8 week over 8 week Ending July 24th 15% growth 4 week over 4 week Ending July 24th
FOR INVESTOR PRESENTATION PURPOSES ONLY. Deepen Prescribing with Core Targets 1 HCP Engagement Expansion of Direct to Consumer Communications IMVEXXY Field Force Support Along with DTC Promotion Are Key to Accelerate Growth in the Second Half of 2020 15K IMVEXXY Writers 6 K 80% of volume ▪ 30% salesforce weighting ▪ Focus on Efficacy Message in combination with Patient Convenience/Satisfaction Attributes ▪ Media: Expanded multichannel marketing including custom KOL video programs ▪ New consumer campaign (August) ▪ Expansion of mediums to display, patient testimonials, videos, social ▪ Adherence and affordability messaging and programs 14 1 Data Source: Prescriber data per IQVIA/TXMD Copay card data
FOR INVESTOR PRESENTATION PURPOSES ONLY. 300 600 900 1200 1500 July June May Apr Mar Feb Jan Dec Nov ANNOVERA Monthly TRx 2Q20 Key Performance Metrics: ANNOVERA 47% growth 8 weeks ended July 24 th over 8 weeks ended 2/28 2Q 2020 TRx to patients ~2,400 # Prescribers w/ TRx ~1,100 Adjudication rate ~99% 15 ▪ Vast majority of patients paying $0 copay ▪ Contraception is the largest women’s health category valued at $5B from 18M women Source: Symphony 100% growth 8 week over 8 week Ending Week of July 24 th vs previous 8 weeks Data Source: Prescription data per Symphony Health PHAST Data through 7/24/2019
FOR INVESTOR PRESENTATION PURPOSES ONLY. ANNOVERA Acceleration throughout Q2 from Fast Adaptation in a Virtual World 250+ HCPs attended virtual speaker programs in Q2 43% of calls in June were live vs. 11% in May 95% of Sales Representatives were making live calls in June Adapted to a Hybrid Selling Model Expanded Virtual Offerings for Healthcare Providers Expanded Opportunities within Telehealth Total of 5 active online platforms All trademarks are the property of their respective owners.
FOR INVESTOR PRESENTATION PURPOSES ONLY. ANNOVERA – Positive Market Reception ▪ NuvaRing writers ▪ Low IUD writers ▪ Average Age of 31 ▪ Likely switching from current birth control ▪ Option for providers who do not do IUD procedures ▪ Procedure - free option that fits lifestyle of women moving away from current birth - control WHO ARE OUR PRESCRIBERS WHO ARE OUR CONSUMERS WHAT ARE THE INSIGHTS 17
FOR INVESTOR PRESENTATION PURPOSES ONLY. Expectations for a Successful Brand Data Source : Symphony Health PHAST Data 18 Contraception Market Size ANNOVERA Revenue at Different S hares Time to Achieve 4 - 5% Market Share $5 billion market size 28 million new prescriptions annually 18 million women Lo - Loestrin - ~4 years NuvaRing - ~5 years 1%: 180K Rx, ~$360M 2%: 360K Rx, ~$720M 3%: 540K Rx, ~$1.1B 4%: 720K Rx, ~$1.4B 5%: 900K Rx, ~$1.8B All trademarks are the property of their respective owners.
FOR INVESTOR PRESENTATION PURPOSES ONLY. ANNOVERA Consumer Campaign Launched on July 1 st The Idea There’s a cultural stigma around birth control and women’s reproductive health that keeps us from being direct and clear about it all. ANNOVERA wants to finally have an open and honest conversation. The Focus Candid conversation The Voice Alternative, Straightforward The Line Unapologetically ANNOVERA 19
FOR INVESTOR PRESENTATION PURPOSES ONLY. ANNOVERA Consumer Campaign Gaining Traction and Visibility within First Month ▪ 100M impressions and 3.1M YouTube views of the campaign video in less than a month ▪ 293K visitors to website ▪ Pick up across media showing culture relevance of product and campaign ▪ USA Today circulation of 58M ▪ Women’s Health circulation of 15M 6/30: USA Today (58M+ impressions) : Coronavirus baby boom may actually be a 'baby bust' as experts see spike in birth control orders • At the start of the COVID - 19 pandemic, there were predictions of a baby boom post - pandemic. The article states that a Guttmacher survey of more than 2,000 women ages 18 - 49 from April 30 to May 6 found that more than 40% of them changed their plans about when to have children or how many children to have due to the pandemic. The article also cited Dr. Minkin , who advised that more people are considering ANNOVERA as an option for birth control during this time, because it is long - acting, reusable and reversible. July/August: Women’s Health (15M impressions): “Total Control: Contraceptive Innovations Are Inching Closer Than Ever to Perfection When It Comes to Comfort, Convenience, and Consistent Success. Come Along, Let’s Find Your Best New Option” *Data 7/1 - 7/26 per Google Analytics 20
FOR INVESTOR PRESENTATION PURPOSES ONLY. Investment in ANNOVERA Consumer Marketing Remainder of Year 300 million readers every month 32 million fans and followers Reach 1 in 2 female millennials in the US Consumer Launch JULY POPSUGAR Takeover AUGUST Influencers SEPTEMBER Expanded Mediums and PR Campaign Q4 21
FOR INVESTOR PRESENTATION PURPOSES ONLY. Growth Catalyst: High Future Refill Rate *Questionnaires were administered and completed at cycle 3 by 1036 of the 1135 subjects enrolled in the Phase 3 trial (91%) and 811 subjects at cycle 13. Merkatz et al. Contraception . 2014;90(5):514 - 521 . 22 ▪ After 1 year of use: • 85% of the women indicated that they would consider using ANNOVERA if it were free • 75% of the women indicated that they would consider using ANNOVERA, even if they had to pay for it ▪ Vast majority of patients have a $0 copay Phase 3 acceptability study (n=1036 women) 1*
FOR INVESTOR PRESENTATION PURPOSES ONLY. Growth Catalysts by Channel 23 Commercial Public Health Military Online/TeleHealth % OF MARKET 1 76% 15% Less than 5% Emerging and growing channel RESOURCE Sales Force Afaxys : #1 provider of contraception in Medicaid channel WSI: specialized DoD prescription sales force 5 online platforms STAGE • Launched to core 20K providers with salesforce • Marketing focused on white space expansion • Title X (Planned Parenthood) available to order or send script to pharmacy • Universities • Rollout was delayed due to COVID - 19 • Achieved local formulary at 14 of 92 bases • 13 bases have ordered • All online platforms now live • Expect accelerated growth in 3Q20 and 4Q20 1 Data Source : Symphony Health PHAST Data and Government Reporting for Medicaid and TriCare
FOR INVESTOR PRESENTATION PURPOSES ONLY. BIJUVA Monthly TRx 8.43 8.92 9.62 9.11 9.19 9.3 8 8.5 9 9.5 10 JAN FEB MAR APR MAY JUNE Thousands Source: Symphony 2Q 2020 TRx to patients ~27,600 # Prescribers w/ TRx ~4,200 Overall adjudication rate ~56% 2Q20 Key Performance Metrics: BIJUVA 24 Data Source: Prescription data per Symphony Health PHAST Data through 7/24/2019 Maintain Brand Loyalists • Targeted approach with team also supporting Bio - Ignite
FOR INVESTOR PRESENTATION PURPOSES ONLY. Regulation of the Compounding Industry 25 NASEM Report and Recommendations: https://www.nap.edu/resource/25791/cBHT%20Consensus%20Study%20Report%20Highlights.pdf https://www.nap.edu/resource/25791/cBHT%20Recommendations%20Insert.pdf Link to c ompound ing industry response: https://anh - usa.org/fda - bioidenticals - are - public - health - concern - ban - likely/ National Academies of Science, Engineering and Medicine ( NASEM ) • Report commissioned by FDA and published on July 1, 2020 looking at bio - identical compounding industry • NASEM recommendations for stronger regulation and discipline around promotion and dispensing of compounded bio - identical hormones • NASEM recommendations have been both praised and rebutted by various stakeholders
FOR INVESTOR PRESENTATION PURPOSES ONLY. Key Takeaways ▪ 2Q20 total net revenue was resilient despite COVID - 19 ▪ Set Sixth Street revenue covenants to reflect the impact of COVID - 19 ▪ Executed a strategic and multifaceted plan to adapt to the new reality of a global pandemic and drive long - term shareholder value ⎯ Swift action to right - size our company, reduction of total operating expenses expected to trend to ~$40M by 4Q20 ⎯ Remain laser focused on reaching goal of EBITDA breakeven on a quarterly basis in 2021 ⎯ Pivoted sales force to operate in a “hybrid” model and support healthcare providers virtually ⎯ Launched into new channels of distribution including telehealth, public health and Department of Defense to accelerate growth ⎯ Reshaped Board of Directors and Management Team ▪ Despite COVID - 19, the Company returned product portfolio to growth which is expected to continue throughout 2020 26
FOR INVESTOR PRESENTATION PURPOSES ONLY. CONTRACEPTION PRENATAL CARE CONTRACEPTION/ FAMILY PLANNING - PERIMENOPAUSE VASOMOTOR SYMPTOMS DYSPAREUNIA (Vulvar & Vaginal Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT Prenatal Vitamins Q&A 27
FOR INVESTOR PRESENTATION PURPOSES ONLY. Appendix 28
FOR INVESTOR PRESENTATION PURPOSES ONLY. The Commercial Plan supports the Portfolio 120 - 130 Sales Reps Afaxys (Public Health) and WSI (VA/Military) ▪ ANNOVERA is our lead product ▪ IMVEXXY is positioned as a second detail ▪ BIJUVA focus on maintaining the brand to leverage the opportunity at the right time Distribution Channels All trademarks are the property of their respective owners. VA/Military Public Health 1 2 Online Platforms Retail Product Focus: National and Regional retail chains Consumer Marketing Plans Across ANNOVERA and IMVEXXY 29