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):
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| (State or Other Jurisdiction of Incorporation) |
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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) |
| 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:
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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 May 6, 2021, TherapeuticsMD, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2021. 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 May 6, 2021, the Company issued a press release announcing the Company’s financial results for its first quarter ended March 31, 2021. 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
| Exhibit Number |
Description | |||
| 99.1 | Press Release from TherapeuticsMD, Inc., dated May 6, 2021, entitled “TherapeuticsMD Announces First Quarter 2021 Financial Results.” | |||
| 99.2 | TherapeuticsMD, Inc. Presentation dated May 6, 2021. | |||
| 104 | Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document). | |||
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: May 6, 2021 | THERAPEUTICSMD, INC. | |||||
| By: | /s/ James C. D’Arecca | |||||
| Name | : James C. D’Arecca | |||||
| Title: | Chief Financial Officer | |||||
Exhibit 99.1
FOR IMMEDIATE RELEASE
TherapeuticsMD Announces First Quarter 2021 Financial Results
- 1Q21 total net revenue increased to $19.9 million -
- 1Q21 total net product revenue increased 60% to $19.6 million compared to 1Q20 -
- ANNOVERA prescriptions continue to grow with increasing consumer support and acceptance -
- Further strengthened ANNOVERA® patent family through June 2039 –
- Significantly improved average net revenue per unit for IMVEXXY® to $61 and BIJUVA® to $69 -
-vitaCare’s divesture process continues in an effort to unlock shareholder value-
- Conference call scheduled for 8:30 a.m. ET today -
BOCA RATON, Fla. – May 6, 2021 – TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare Company, today reported financial results for the first quarter ended March 31, 2021.
“I am pleased with our ongoing execution across the organization, which is in-line with our 2021 operating plan led by ANNOVERA, which performed well in a challenging environment. Our financial performance continues to improve year-over-year. Both menopausal products, IMVEXXY and BIJUVA, had record net revenue per unit. We are also pleased to report that three new ANNOVERA patents were obtained, strengthening durability and extending exclusivity through June 2039. The Company won its appeal for the new low-dose BIJUVA 0.5/100 with the FDA. We are confident that these milestones, together with our existing and new commercial strategies, will continue to deliver strong growth throughout 2021,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD.
First Quarter Review
Total net product revenue for the first quarter of 2021 increased 60% to $19.6 million compared to the first quarter of 2020. When compared to the fourth quarter of 2020, total net product revenue decreased by 13% for the first quarter of 2021.
ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)
| • | ANNOVERA net product revenue increased by $6.5 million to $8.8 million for the first quarter of 2021 as compared to $2.3 million for the first quarter of 2020. |
| • | Net revenue per unit, calculated from sales to wholesalers and pharmacies, was $1,071 for the first quarter of 2021. The Company expects net revenue per unit for ANNOVERA to average approximately $1,100 for the year. |
| • | Approximately 6,240 ANNOVERA prescriptions were dispensed to patients during the first quarter of 2021. ANNOVERA total prescription volume increased 164% for the first quarter of 2021 as compared to the first quarter of 2020. ANNOVERA total prescription volume increased 5% for the first quarter of 2021 as compared to the fourth quarter of 2020. Strong refill rates continued with eligible patients. |
| • | During the first quarter the United States Patent and Trademark Office (USPTO) issued three new ANNOVERA patents, which are now listed in the U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). With these additional patents, the Orange Book lists a total of six patents for ANNOVERA. These newly issued patents protect key properties of ANNOVERA and extend patent protection for ANNOVERA from February 2039 to June 2039. |
IMVEXXY® (estradiol vaginal inserts)
| • | IMVEXXY net product revenue increased by 10% to $7.0 million for the first quarter of 2021 as compared to $6.4 million for the first quarter of 2020. |
| • | Net revenue per unit, calculated from sales to wholesalers and pharmacies, was approximately $61 for the first quarter of 2021 reflecting a 39% improvement in net price compared to the first quarter of 2020. |
| • | The impact of the Company’s increase in cash pay price for IMVEXXY on January 1, 2021, had a positive impact on net revenue per unit and a short-term impact on volume. Approximately 108,200 prescriptions were dispensed to patients during the first quarter of 2021. As expected, IMVEXXY total prescription volume declined 14% for the first quarter of 2021 as compared to the first quarter of 2020. IMVEXXY fill rates remained at an average of approximately 6 fills per patient annually. |
| • | The Company recently launched Long May She Reign, a new consumer campaign for IMVEXXY, designed to educate menopausal women about vaginal health during menopause. |
BIJUVA® (estradiol and progesterone)
| • | BIJUVA net product revenue increased 120% to $2.5 million for the first quarter of 2021 as compared to $1.1 million for the first quarter of 2020. |
| • | Net revenue per unit, calculated from sales to wholesalers and pharmacies, was approximately $69 for the first quarter of 2020 reflecting an 85% improvement in net price as compared to the first quarter of 2020. |
| • | The Company increased the cash pay price for BIJUVA on January 1, 2021, which was expected to have a short-term impact on volume. Approximately 30,800 BIJUVA prescriptions were dispensed to patients in the first quarter of 2021. |
| • | The Company won its appeal for the new low-dose BIJUVA 0.5 mg/100 mg with the FDA. The Company has been granted a meeting with the FDA in May to discuss next steps. |
| • | Theramex, the Company’s licensee, was granted additional European approvals of BIJUVA (1 mg/100 mg). |
Cost of Goods Sold/Gross Margin
| • | Cost of goods was $4.7 million with gross margin of 76% for the first quarter of 2021 as compared to $5.6 million with gross margin of 75% for the fourth quarter of 2020 and $2.7 million with gross margin of 78% for the first quarter of 2020. The Company’s gross margin of 76% for the first quarter of 2021 was adversely affected by production related write-offs for ANNOVERA of $0.9 million. |
Expense, Net Loss and Related Information
| • | Total operating expenses for the first quarter of 2021 decreased by $16 million from $60.5 million to $44.5 million for the first quarter of 2020. Total operating expenses for the first quarter of 2021 decreased by $7.1 million from $51.6 million for the fourth quarter of 2020. |
| • | The decrease in operating expenses was primarily a result of measures initiated by the Company to reduce overall operating expenses. |
| • | Net loss continues to improve. The first quarter of 2021 was $39.4 million, or $0.11 per basic and diluted share, compared with net loss for the first quarter of 2020 of $56.8 million, or $0.21 per basic and diluted share and net loss for the fourth quarter of 2020 of $42.1 million, or $0.15 per basic and diluted share. |
Balance Sheet
| • | As of March 31, 2021, the Company’s cash on hand totaled $137.6 million, compared with $80.5 million as of December 31, 2020. |
| • | The Company received $150.9 million in net proceeds from its at-the-market and underwritten equity offerings and repaid $50 million of principal under its Financing Agreement. The remaining outstanding principal amount under the Financing Agreement is $200 million. |
vitaCare Update
The Company continues the vitaCare divestiture process to unlock shareholder value. The Company believes vitaCare is creating a significant revenue opportunity with two new live customers, a third scheduled to launch in the fourth quarter, and a pipeline with approximately twenty potential new deals. vitaCare continues to build its foundation to become a free-standing entity in a rapidly growing sector with no established leader.
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, May 6, 2021 | |
| Time: | 8:30 a.m. ET | |
| Telephone Access (US): | 866-665-9531 | |
| Telephone Access (International): | 724-987-6977 | |
| Access Code for All Callers: | 5683435 |
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: 5683435.
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 |
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 its vitaCare business and how the proceeds that may be generated by any such divestiture 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)
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| Assets: |
||||||||
| Current assets: |
||||||||
| Cash |
$ | 137,617 | $ | 80,486 | ||||
| Accounts receivable, net of allowance for credit losses of $1,231 and $1,118 as of March 31, 2021 and December 31, 2020, respectively |
33,719 | 32,382 | ||||||
| Inventory |
7,346 | 7,993 | ||||||
| Prepaid and other current assets |
8,360 | 7,543 | ||||||
|
|
|
|
|
|||||
| Total current assets |
187,042 | 128,404 | ||||||
|
|
|
|
|
|||||
| Fixed assets, net |
1,812 | 1,942 | ||||||
| License rights and other intangible assets, net |
40,994 | 41,445 | ||||||
| Right of use assets |
9,205 | 9,566 | ||||||
| Other non-current assets |
253 | 253 | ||||||
|
|
|
|
|
|||||
| Total assets |
$ | 239,306 | $ | 181,610 | ||||
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|||||
| Liabilities and stockholders’ equity (deficit): |
||||||||
| Current liabilities: |
||||||||
| Current maturities of long-term debt |
$ | 5,000 | $ | — | ||||
| Accounts payable |
10,310 | 21,068 | ||||||
| Accrued expenses and other current liabilities |
45,974 | 38,170 | ||||||
|
|
|
|
|
|||||
| Total current liabilities |
61,284 | 59,238 | ||||||
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| Long-term debt, net |
178,970 | 237,698 | ||||||
| Operating lease liabilities |
8,530 | 8,675 | ||||||
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| Total liabilities |
248,784 | 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, 393,190 and 299,765 issued and outstanding as of March 31, 2021 and December 31, 2020, respectively |
393 | 300 | ||||||
| Additional paid-in capital |
908,457 | 754,644 | ||||||
| Accumulated deficit |
(918,328 | ) | (878,945 | ) | ||||
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| Total stockholders’ deficit |
(9,478 | ) | (124,001 | ) | ||||
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| Total liabilities and stockholders’ equity (deficit) |
$ | 239,306 | $ | 181,610 | ||||
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TherapeuticsMD, Inc.
Consolidated Statements of Operations
(Unaudited - in thousands, except per share data)
| Three Months Ended | ||||||||||||
| March 31, | December 31, | |||||||||||
| 2021 | 2020 | 2020 | ||||||||||
| Product revenue, net |
$ | 19,632 | $ | 12,251 | $ | 22,577 | ||||||
| License revenue |
234 | — | — | |||||||||
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| Total revenue, net |
19,866 | 12,251 | 22,577 | |||||||||
| Cost of goods sold |
4,687 | 2,715 | 5,581 | |||||||||
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| Gross profit |
15,179 | 9,536 | 16,996 | |||||||||
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| Operating expenses: |
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| Selling, general and administrative |
42,407 | 57,189 | 49,210 | |||||||||
| Research and development |
2,050 | 3,269 | 2,394 | |||||||||
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| Total operating expenses |
44,457 | 60,458 | 51,604 | |||||||||
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| Loss from operations |
(29,278 | ) | (50,922 | ) | (34,608 | ) | ||||||
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| Other (expense) income: |
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| Interest expense and other financing costs |
(10,227 | ) | (6,262 | ) | (7,613 | ) | ||||||
| Other income, net |
122 | 335 | 133 | |||||||||
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| Other (expense), net |
(10,105 | ) | (5,927 | ) | (7,480 | ) | ||||||
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| Loss before income taxes |
(39,383 | ) | (56,849 | ) | (42,088 | ) | ||||||
| Provision for income taxes |
— | — | — | |||||||||
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| Net loss |
$ | (39,383 | ) | $ | (56,849 | ) | $ | (42,088 | ) | |||
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| Loss per common share, basic and diluted |
$ | (0.11 | ) | $ | (0.21 | ) | $ | (0.15 | ) | |||
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| Weighted average common shares, basic and diluted |
347,219 | 271,460 | 286,607 | |||||||||
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TherapeuticsMD, Inc.
Consolidated Statements of Cash Flows
(Unaudited - in thousands, except per share data)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2021 | 2020 | |||||||
| Cash flows from operating activities: |
||||||||
| Net loss |
$ | (39,383 | ) | $ | (56,849 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
| Depreciation and amortization |
1,019 | 1,008 | ||||||
| Charges (credits) to provision for doubtful accounts |
230 | (123 | ) | |||||
| Inventory charge |
502 | 136 | ||||||
| Debt financing fees |
1,272 | 320 | ||||||
| Non-cash operating lease expense |
216 | 352 | ||||||
| Share-based compensation |
2,957 | 2,366 | ||||||
| Impairment of other intangible assets and operating lease |
— | |||||||
| Changes in operating assets and liabilities |
||||||||
| Accounts receivable |
(1,567 | ) | 3,855 | |||||
| Inventory |
145 | (2,883 | ) | |||||
| Prepaid and other current assets |
(817 | ) | 4,436 | |||||
| Other assets |
— | — | ||||||
| Accounts payable |
(10,758 | ) | 9,533 | |||||
| Accrued expenses and other current liabilities |
7,804 | (1,262 | ) | |||||
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| Total adjustments |
1,003 | 17,738 | ||||||
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| Net cash used in operating activities |
(38,380 | ) | (39,111 | ) | ||||
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| Cash flows from investing activities: |
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| Payment of patent related costs |
(375 | ) | (422 | ) | ||||
| Purchase of fixed assets |
(63 | ) | (21 | ) | ||||
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| Net cash used in investing activities |
(438 | ) | (443 | ) | ||||
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| Cash flows from financing activities: |
||||||||
| Proceeds from sale of common stock, net of costs |
150,899 | — | ||||||
| Proceeds from exercise of options and warrants |
50 | 72 | ||||||
| Repayments of debt |
(50,000 | ) | — | |||||
| Borrowings of debt |
— | 50,000 | ||||||
| Payment of debt financing fees |
(5,000 | ) | (1,250 | ) | ||||
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| Net cash provided by financing activities |
95,949 | 48,822 | ||||||
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| Net increase in cash |
57,131 | 9,268 | ||||||
| Cash, beginning of period |
80,486 | 160,830 | ||||||
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| Cash, end of period |
$ | 137,617 | $ | 170,098 | ||||
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| Supplemental disclosure of cash flow information Interest paid |
$ | 8,955 | $ | 5,893 | ||||
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Investor Contacts
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
In-Site Communications, Inc.
Lisa M. Wilson
212-452-2793
lwilson@insitecony.com
Building the Premier Women’s Health Company 1Q 2021 Earnings May 6, 2021 Exhibit 99.2
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 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, including the minimum net revenue and minimum cash covenants; whether the company will be able to successfully divest its vitaCare business and how the proceeds that may be generated by such divestiture will be used; 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 ability to grow the company’s vitaCare business; 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.
Summary of Q1 Performance Strong execution in the first quarter aligned with operating plan to drive shareholder value ANNOVERA Remains #1 priority in portfolio Refined commercial strategies to address both short and long-term impacts from COVID-19 New patents improve durability and exclusivity to June 2039 MENOPAUSE FRANCHISE Highest net revenue per unit for both IMVEXXY and BIJUVA Won appeal with FDA for low dose 0.5/100 BIJUVA vitaCare Prescription Services Divestiture process continues to unlock shareholder value 2 new customers go live plus strong pipeline with approximately 20 potential customers Continue to build foundation to become free-standing entity in a rapidly growing sector with no clear market leader
1Q21 Financial Overview
Quarterly Net Revenue Trends Millions 1Q21 Highlights Total net product revenue increased 60% 1Q21 vs 1Q20 ANNOVERA net revenue increased 285% Average net revenue per unit $1,071(1) IMVEXXY net revenue increased 10% Average net revenue per unit $61(1) BIJUVA net revenue increased 120% Average net revenue per unit $69(1) Improved net revenue per unit 13% for IMVEXXY and 33% for BIJUVA in 1Q21 versus 4Q20 Menopausal franchise has historically retracted in 1Q versus 4Q due to high deductible and copay resets $12.3 Quarterly Net Product Revenue 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. $19.6 $22.6
Financial Results: Comparison 1Q 2021 to 4Q 2020 and 1Q 2020 Reduced debt to $184M by a $50M cash payment Gross Margin of 76% Impacted by write-offs of production related costs for ANNOVERA of $0.9M Reduced operating expenses by $16M to $44.5M as compared to 1Q20 Net cash used in operating activities decreased to $38.4M 1Q21 4Q20 1Q20 Balance Sheet(1) Cash $137,617 $80,486 $170,098 Debt $183,970 $237,698 $243,429 Income Statement Net Product Revenue $19,632 $22,577 $12,251 Gross Profit from Products $14,945 $16,996 $9,536 Gross Margin % 76% 75% 78% Total Operating Expenses $44,457 $51,604 $60,458 Net loss ($39,383) ($42,088) ($56,849) Statement of Cash Flow Net Cash Used In Operating Activities ($38,380) ($30,357) ($39,111) (1) Balance Sheet as of quarter end. Comparison of Key Financial Statement Items [in 1,000’s]
ANNOVERA: Unique Opportunity to Create a New Segment within Birth Control
ANNOVERA Quarterly TRx Source: Prescription data per Symphony Health PHAST Data. ANNOVERA TRX: Continued Growth Through COVID-19 1Q21 Key Metrics 164% YOY and 5% QOQ TRx growth Net revenue per unit at $1,071 Expect annual net revenue per unit to average ~$1,100 for the year ~17% increase in prescribers with a prescription in 1Q21 compared to 4Q20 (~3,160 vs ~2,700) Refill rates remain at ~50%
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 Q4 2020 Q1 2021 Oral Contraception 22% 22% NuvaRing & Generics 53% 43% Injection/Patch 13% 11% IUD/Implant 8% 18% New to Birth Control 5% 6% The majority of ANNOVERA patients are new to rings Source: vitaCare patient survey data.
Payor Update: Progress In Spite of Express Scripts (ESI) Formulary Removal Coverage April 21, 2021 Commercial 57% UR, 66%(1) Medicaid 56%(2) Department of Defense On Formulary Commercial 75% Part D 37%+(3) Commercial 78% Note: (1) 66% covered with prior authorization (PA) / step edit; UR=unrestricted. (2) ANNOVERA Medicaid Note: estimated coverage will increase from 40% in April to ~56% on when MediCal controls all the Medicaid Managed Care formularies in California. (3) Includes lives with PA to indication only. (4) https://www.express-scripts.com/art/open_enrollment/DrugListExclusionsAndAlternatives.pdf, Accessed 4/29/2021. Source: MMIT as of April 2021. Recent changes to access: Effective April 1st, 2021, ESI replaced branded contraceptives with generics on formulary and placed branded contraceptives on the drug exclusion list. This included ANNOVERA. ESI patients continue to receive ANNOVERA when their prescribers submit Letters of Medical Necessity (LMN) through the protection of the Affordable Care Act (ACA)
Prescriber Access Still an Ongoing Challenge, but COVID-19 Headwinds Beginning to Recede HCPs believe in-person visit volume may double from current levels within a year, but a sizeable gap to pre-COVID levels will continue TXMD access currently at 40%: Successfully supplementing access with innovative, live and virtual programs Pre-Covid Baseline (100%) 27%
NRx Trend of Recently Launched Mass Market Product Volumes Symphony Health National Level Data. All trademarks are property of their respective owners. Brand Name Indication Mar-21 Feb-21 Jan-21 Dec-20 ANNOVERA Contraception - TXMD 2,145 1,724 1,770 1,728 Phexxi Contraception 4,282 2,446 1,819 1,612 Twirla Contraception 623 430 270 104 Slynd Contraception 14,726 12,077 12,388 11,923 Orilissa Endometriosis 5,918 5,125 5,420 5,668 Solosec Bacterial Vaginosis 2,867 2,461 2,817 3.378 Aklief Acne 15,000 11,668 12,631 14,332 Winlevi Acne 14 15 5 Klisyri Actinic Keratosis 733 48 Dayvigo Insomnia 8,772 6,892 6,396 6,332 Nexletol Cholesterol 3,829 3,112 2,963 2,947 Nurtec ODT Migraine 36,644 30,904 30,460 32,413 Reyvow Migraine 1,837 1,539 1,430 1,620 Vyepti Migraine 78 48 28 55 Ubrelvy Migraine 44,480 35,690 35,350 38,850 Rhopressa Elevated Eye Pressure 14,841 12,020 13,226 14,020 Rocklatan Elevated Eye Pressure 9,378 7,812 8,358 8,714 COVID’s impact on recently launched brands
COVID-19 challenges have created a faster shift to technology solutions Increasing breadth of telemedicine solutions and services for patients Digital allows for fast data, learning and adaptation Capability built across organization in change management "Fast" pilot, pivot, production COVID-19 Constraints Accelerated New Ways to Engage with Consumers
ANNOVERA's Attributes Create Significant Interest with Consumers, but Access to Patients Remains Difficult ANNOVERA consumer campaign drove over 2M visitors to the website from July 2020-March 2021 *Reflects single-source data transformed to reflect full digital business from July 2020 to March 2021 Only 2% of the 2.1M decided to start the process of getting ANNOVERA online Only 20% of those who started the process of getting ANNOVERA online get to the final step of obtaining a prescription Only 45% who obtained a prescription get it filled 2.1M Visitors to ANNOVERA.com 42K (2%) began effort to get ANNOVERA online 8K * scripts written (20%) 3.5K * scripts filled (45%)
Goal: Translate Significant Interest into Increased Consumers that can Access ANNOVERA ANNOVERA Campaigns Drive High level of Interest Latest round of banner ads are double the industry benchmark (.19%) Vagina Appreciation Day PR event drove a 380% increase in organic search and drove a 35% increase to the website 2.1M Visitors to ANNOVERA.com 42K (2%) began effort to get ANNOVERA online 8K scripts written (20%) 3.5K scripts filled (45%)
Goal: Increase Breadth of Options for Consumers to Access ANNOVERA Opportunity to help more women who choose to get ANNOVERA online Website enhancements that provide clear information on how to “take action” Increased breadth of options to “Get ANNOVERA” Talk to a doctor now Fill out information to see if you qualify Support for patient to reach out to their doctor 2.1M Visitors to ANNOVERA.com 42K (2%) began effort to get ANNOVERA online 8K scripts written (20%) 3.5K scripts filled (45%)
Goal: Improve Rate of those that Receive a Prescription Telehealth improving each quarter: 30% increase in prescriptions from telehealth quarter over quarter, the fastest growing channel for ANNOVERA Increase dependent on breadth of options and efficiency of the process In Q1, pilot programs demonstrated ability to help more women who wanted ANNOVERA receive a prescription; program is now being expanded Opportunity to help more women who want ANNOVERA actually receive a prescription *Reflects single-source data transformed to reflect full digital business from July 2020 to March 2021 2.1M Visitors to ANNOVERA.com 42K (2%) began effort to get ANNOVERA online 8K * scripts written (20%) 3.5K scripts filled (45%)
Goal: Increase the Fill Rate Once a Prescription is Written Solution: Use of vitaCare to support patients receiving an ANNOVERA Prescription Launched April 13th Opportunity to increase from ~45% Reasons for drop off are cost/coverage issues Industry fill rate average is ~50% With vitaCare support, before sending to a retail/mail order pharmacy, the fill rate is ~70% for IMVEXXY/BIJUVA *Reflects single-source data transformed to reflect full digital business from July 2020 to March 2021 2.1M Visitors to ANNOVERA.com 42K (2%) began effort to get ANNOVERA online 8K * scripts written (20%) 3.5K * scripts filled (45%)
ANNOVERA Solutions to Grow Access to Patients Continue on the path we are on today with a combination of our consumer campaign and public relations events Website enhancements that provide clearer guidance on how to "take action" Increase breadth of options for a patient to access a healthcare provider Improve efficiency of process to connect with a healthcare provider Use of vitaCare support for patients SOLUTIONS *Reflects single-source data transformed to reflect full digital business from July 2020 to March 2021 2.1M Visitors to ANNOVERA.com 42K (2%) began effort to get ANNOVERA online 8K * scripts written (20%) 3.5K * scripts filled (45%)
ANNOVERA’s exclusivity position has significantly improved over the last 12 months Three new patent issuances in 2021 that offer improved strategic value and durability Further patent work is on-going Six patents listed in the Orange Book Most recent patents extend patent exclusivity from February of 2039 to June 2039 ANNOVERA Intellectual Property
IMVEXXY: Fastest Growing Branded Product in Vulvar and Vaginal Atrophy Category
IMVEXXY Performance Drivers Source: Prescription data per Symphony Health PHAST Data. IMVEXXY Weekly NRx Thousands IMVEXXY Quarterly Performance IMVEXXY 1Q21 Performance IMVEXXY volume trends across the past year aligned with VVA market Loss of TRx Q1 vs. Q4 due to cash pay shift 1Q historically lower than 4Q due to the impact of high deductible insurance plans resetting Net revenue per unit improved to $61 offsetting volume losses Expect annual blended net price to be in a range of ~$65 to ~$75 average for 2021 ~2% increase in prescribers writing a prescription in 1Q21 compared to 4Q20 (~13,745 vs ~13,500) Average of ~6 fills per patient annually
2021 IMVEXXY Strategic Initiatives: Status Update IMVEXXY Weekly TRx As expected, short-term impact on volume Jan 1st Cash Pay Changed to $75 IMVEXXY back to strong growth post cash pay change Realize Higher Net Pricing Data Source: Prescription data per Symphony Health PHAST Data.
IMVEXXY Net Price Build Shows Improvement 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 previous “calculated net revenue per unit” which used units sold to patients in the quarter. (1) 39% improvement in net price for 1Q21 compared to 1Q20 13% improvement in net price for 1Q21 compared to 4Q20
REIGN YOU TUBE Quant (% Based on all Respondents) Audio and video cannot be skipped for 5 seconds Once engaged, most remain 29 = 19% IMVEXXY Campaign Quantitative Test, N=150, Oct. 2020 August-September 2020 Results. Display CTR 0.08% CTR: Click through rate. VCR: Video Completion Rate 1 in 4 1 in 5 Consumer Campaign, Reign Launched April 26th START VIDEO (1s +) WATCHING AT 8 SEC TAKE ACTION TALK TO DOCTOR WATCH FULL VIDEO 29= 19% 39 = 26% 150 = 100% 144 = 96% 113 = 75%
BIJUVA: First and Only FDA-Approved Bio-Identical Solution in Vasomotor Symptoms (VMS) Market
Thousands Source: Symphony Data Source: Prescription data per Symphony Health PHAST Data. BIJUVA Quarterly Performance BIJUVA Volume Increased YoY with Limited Focus BIJUVA 1Q21 Trends Loss of TRx due to copay shift that is now rebounding ~3% increase in prescribers writing a prescription in 1Q21 compared to 4Q20 (~4,900 vs ~4,750) 1Q historically lower than 4Q due to the impact of high deductible insurance plans resetting Net revenue per unit improved to $69 Targeted approach with supporting Bio-Ignite to maintain brand loyalists with 7 sales representatives
BIJUVA 0.5 mg/100 mg - Update Formal Dispute Resolution Request granted by FDA APPEAL GRANTED “Study TXC12-05 has provided sufficient data for approval of the 0.5 mg/100 mg dose of Bijuva” “Sufficient evidence from other data provided in your original NDA” Type B meeting scheduled on 05/12/2021 to discuss: Resubmission and label discussions
Key Takeaways Improved cash position Lowered debt by $50M Increased revenue growth while significantly lowering operating expenses by $16.0M YOY Record nets per unit for menopausal products vitaCare process continues and strong execution enhances divesture value TXMD performance aligned with 2021 operating plan Goal of achieving EBITDA breakeven on a quarterly basis in 1H22
Q&A
Appendix
Leading Indicator of Potential Future Growth: ANNOVERA Writers Continue to Grow Growth across all categories of targets that are sales force driven Growth across non-targets that are marketing driven Key Takeaways
ANNOVERA Goal: Become a New Segment in Birth Control Daily Weekly Monthly 3-10 Years Annual, Procedure Free SHORT-ACTING LONG-ACTING 3 mo. injection Short-Acting Decline –4.2% CAGR(1) 1 Year Long-Acting Growth +15% CAGR(1) Note: (1) Based on company filings. Market Void
Goal: Supplement Reach and Frequency of Salesforce to Providers through Innovative Programs Fireside Chats: Deep Dives on ANNOVERA by qualified Healthcare Providers in conjunction with a sales representative Since inception in Q4, ~500 events conducted 845 unique HCP attendees 14 self-scheduled events without a representative 99 events scheduled for May Activation of new prescribers (167) Reactivation of lapsed writers Results