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) |
|
|
|
|
|
|
|
(State or Other Jurisdiction of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer |
|
|
|
(Address of Principal Executive Office) (Zip Code) |
Registrant’s telephone number, including area code:
|
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 |
|
|
|
|
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. |
The information provided in Item 7.01 of this Current Report on Form 8-K is incorporated in this Item 2.02 by reference.
|
Item 7.01 |
Regulation FD Disclosure. |
On November 14, 2022, the Company issued a press release announcing its financial results for the third quarter ended September 30, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 7.01 and the information contained in Exhibit 99.1 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 |
|||
|
|
|
||
|
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: November 14, 2022 |
|
THERAPEUTICSMD, INC. |
|
|
|
|
|
|
|
/s/ Michael C. Donegan |
|
|
|
Michael C. Donegan |
|
|
|
Interim Chief Financial Officer, Chief Accounting Officer and Vice President Finance |
Exhibit 99.1
TherapeuticsMD Announces Third Quarter 2022 Financial Results
- Q3 total revenue of $20.9 million -
- ANNOVERA TRx growth of 10% year-over-year -
- Reduced operating expenses by $22 million year-over-year -
BOCA RATON, Fla. – November 14, 2022 – TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the third quarter ended September 30, 2022.
“Our products continue to be adopted by healthcare providers and patients, and we continue to believe that they represent a significant opportunity. Our prescriber bases grew, and we added around 1,500 new prescribers for ANNOVERA and around 1,600 for IMVEXXY. Total quarterly prescriptions for both products remained relatively stable compared to the second quarter of 2022, and ANNOVERA’s total prescriptions grew 10% compared to the third quarter of 2021. While our third quarter 2022 net revenues declined $4.5 million compared with the prior year, through disciplined cost control measures, we were able to reduce operating expenses by $22 million year-over-year,” said Mark Glickman, co-Interim-CEO of TherapeuticsMD.
“During the quarter, we were able to move past the inventory issues we experienced in the first half of the year, and our wholesale network is now fully stocked. With these developments and the recent cash infusion from Rubric Capital, we believe our operations have stabilized, and we continue on our path forward toward our goal of meeting the demand for our products and helping to advance women’s health,” added Glickman. “Our Board of Directors and management team continue to actively assess strategic alternatives to strengthen the Company’s long-term financial position.” concluded Glickman.
Third Quarter 2022 Financial Results and Business Highlights
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
Product revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANNOVERA |
|
$ |
10,415 |
|
|
$ |
11,807 |
|
|
$ |
37,196 |
|
|
$ |
30,112 |
|
|
IMVEXXY |
|
|
6,947 |
|
|
|
8,016 |
|
|
|
20,583 |
|
|
|
24,866 |
|
|
BIJUVA |
|
|
2,663 |
|
|
|
3,298 |
|
|
|
7,877 |
|
|
|
7,899 |
|
|
Prescription vitamin |
|
|
892 |
|
|
|
1,335 |
|
|
|
2,671 |
|
|
|
4,162 |
|
|
Product revenue, net |
|
|
20,917 |
|
|
|
24,456 |
|
|
|
68,327 |
|
|
|
67,039 |
|
|
License and service revenue |
|
|
— |
|
|
|
950 |
|
|
|
484 |
|
|
|
1,234 |
|
|
Total revenue, net |
|
$ |
20,917 |
|
|
$ |
25,406 |
|
|
$ |
68,811 |
|
|
$ |
68,273 |
|
ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system)
|
|
• |
ANNOVERA net product revenue of $10.4 million for the third quarter of 2022 decreased by $1.4 million compared to $11.8 million for the third quarter of 2021. |
|
|
• |
Approximately 9,200 ANNOVERA prescriptions were dispensed to patients during the third quarter of 2022. |
|
|
• |
Over 15,000 healthcare providers (HCPs) prescribed ANNOVERA since launch through the third quarter of 2022, of which more than 1,500 were new writers. |
IMVEXXY® (estradiol vaginal inserts)
|
|
• |
IMVEXXY net product revenue of $6.9 million for the third quarter of 2022 decreased by $1.1 million compared to $8.0 million for the third quarter of 2021. |
|
|
• |
Approximately 91,300 IMVEXXY prescriptions were dispensed to patients during the third quarter of 2022. |
BIJUVA® (estradiol and progesterone) capsules
|
|
• |
BIJUVA net product revenue of $2.7 million for the third quarter of 2022 decreased by approximately $0.6 million compared to $3.3 million for the third quarter of 2021. |
|
|
• |
BIJUVA net product revenue for the third quarter of 2022 includes $0.4 million of export sales through our international licensing and supply agreement with Theramex HQ UK Limited. |
Cost of Goods Sold and Gross Margin
|
|
• |
Cost of goods was $3.8 million with product gross margin of 82% for the third quarter of 2022 compared to $5.3 million with product gross margin of 78% for the third quarter of 2021. The increase in product gross margins was mainly due to changes in product sales mix. |
Operating Expense, Net Loss and Related Information
|
|
• |
Total operating expense of $37.9 million for the third quarter of 2022 decreased by approximately $22.2 million compared to $60.0 million for the third quarter of 2021. |
|
|
• |
Net loss for the third quarter of 2022 was $29.0 million, or $3.13 per basic and diluted share, compared to net loss for the third quarter of 2021 of $47.4 million, or $5.62 per basic and diluted share. |
Balance Sheet
|
|
• |
As of September 30, 2022, the Company’s cash on hand totaled $27.1 million, compared with $65.1 million as of December 31, 2021. Subsequent to quarter end, the Company closed a $7 million private investment in the Company’s Series A Preferred Stock from Rubric Capital Management LP. The Company also had $11.3 million in restricted cash related to customary holdbacks as part of the vitaCare Prescription Services divestiture. |
|
|
• |
As of September 30, 2022, the Company’s aggregate balance of net debt, lender warrants derivative liability, make-whole payment derivative liability and mandatory redeemable preferred stock was $117.1 million. |
In light of the Company’s ongoing strategic alternatives process, the Company will not be hosting a conference call.
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: whether the company will be able to refinance the indebtedness under its term loan facility, and, if not, whether the company will be able to continue as a going concern; whether the company will be able to raise capital to fund its operations; whether and how the executive order on contraception is implemented; 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; the effects of supply chain issues on the supply of the company’s products; 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; the company’s ability to protect its intellectual property; 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 impact of leadership transitions; and the volatility of the trading price of the company’s common stock.
- Financial Statements to Follow -
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited - in thousands, except per share data)
|
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
||
|
Assets: |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash |
|
$ |
27,080 |
|
|
$ |
65,122 |
|
|
Restricted cash |
|
|
11,250 |
|
|
|
— |
|
|
Accounts receivable, net of allowance for credit losses of $1,621 and $1,334 as of September 30, 2022 and December 31, 2021, respectively |
|
|
32,157 |
|
|
|
36,176 |
|
|
Inventory |
|
|
6,701 |
|
|
|
7,622 |
|
|
Prepaid and other current assets |
|
|
10,290 |
|
|
|
10,548 |
|
|
Total current assets |
|
|
87,478 |
|
|
|
119,468 |
|
|
Fixed assets, net |
|
|
551 |
|
|
|
1,199 |
|
|
License rights and other intangible assets, net |
|
|
37,876 |
|
|
|
40,318 |
|
|
Right of use assets |
|
|
7,749 |
|
|
|
8,234 |
|
|
Other non-current assets |
|
|
253 |
|
|
|
253 |
|
|
Total assets |
|
$ |
133,907 |
|
|
$ |
169,472 |
|
|
Liabilities and stockholders' deficit: |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Debt, net |
|
$ |
93,602 |
|
|
$ |
188,269 |
|
|
Lender Warrants derivative liability |
|
|
2,058 |
|
|
|
— |
|
|
Make-whole payment derivative liability |
|
|
1,751 |
|
|
|
— |
|
|
Mandatory Redeemable Preferred Stock |
|
|
19,709 |
|
|
|
— |
|
|
Accounts payable |
|
|
13,383 |
|
|
|
20,318 |
|
|
Accrued expenses and other current liabilities |
|
|
43,568 |
|
|
|
44,304 |
|
|
Total current liabilities |
|
|
174,071 |
|
|
|
252,891 |
|
|
Operating lease liabilities |
|
|
7,553 |
|
|
|
8,063 |
|
|
Other non-current liabilities |
|
|
554 |
|
|
|
2,139 |
|
|
Total liabilities |
|
|
182,178 |
|
|
|
263,093 |
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
Stockholders' deficit: |
|
|
|
|
|
|
|
|
|
Preferred stock, par value $0.001; 10,000 shares authorized, 22 issued |
|
|
|
|
|
|
|
|
|
and included in liabilities due to their redemption provisions |
|
|
— |
|
|
|
— |
|
|
Common stock, par value $0.001; 12,000 shares authorized, 9,467 and 8,598 (adjusted for the 50-for-1 reverse stock split) shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively |
|
|
9 |
|
|
|
9 |
|
|
Additional paid-in capital |
|
|
968,785 |
|
|
|
957,730 |
|
|
Accumulated deficit |
|
|
(1,017,065 |
) |
|
|
(1,051,360 |
) |
|
Total stockholders' deficit |
|
|
(48,271 |
) |
|
|
(93,621 |
) |
|
Total liabilities and stockholders' deficit |
|
$ |
133,907 |
|
|
$ |
169,472 |
|
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited - in thousands, except per share data)
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
Revenue, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
$ |
20,917 |
|
|
$ |
24,456 |
|
|
$ |
68,327 |
|
|
$ |
67,039 |
|
|
License and service |
|
|
— |
|
|
|
950 |
|
|
|
484 |
|
|
|
1,234 |
|
|
Total revenue, net |
|
|
20,917 |
|
|
|
25,406 |
|
|
|
68,811 |
|
|
|
68,273 |
|
|
Cost of goods sold |
|
|
3,788 |
|
|
|
5,282 |
|
|
|
13,388 |
|
|
|
14,101 |
|
|
Total gross profit |
|
|
17,129 |
|
|
|
20,124 |
|
|
|
55,423 |
|
|
|
54,172 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
19,129 |
|
|
|
30,005 |
|
|
|
61,703 |
|
|
|
86,193 |
|
|
General and administrative |
|
|
17,635 |
|
|
|
28,435 |
|
|
|
55,445 |
|
|
|
66,691 |
|
|
Research and development |
|
|
1,112 |
|
|
|
1,605 |
|
|
|
4,092 |
|
|
|
5,666 |
|
|
Total operating expenses |
|
|
37,876 |
|
|
|
60,045 |
|
|
|
121,240 |
|
|
|
158,550 |
|
|
Loss from operations |
|
|
(20,747 |
) |
|
|
(39,921 |
) |
|
|
(65,817 |
) |
|
|
(104,378 |
) |
|
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of business |
|
|
— |
|
|
|
— |
|
|
|
143,384 |
|
|
|
— |
|
|
Expense for accretion of Mandatory Redeemable Preferred Stock |
|
|
(3,457 |
) |
|
|
— |
|
|
|
(3,457 |
) |
|
|
— |
|
|
Fair value loss on Lender Warrants derivative liability |
|
|
(76 |
) |
|
|
— |
|
|
|
(76 |
) |
|
|
— |
|
|
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(8,380 |
) |
|
|
— |
|
|
Interest expense and other financing costs |
|
|
(4,833 |
) |
|
|
(7,518 |
) |
|
|
(30,941 |
) |
|
|
(25,341 |
) |
|
Other (expense) income, net |
|
|
(112 |
) |
|
|
19 |
|
|
|
(128 |
) |
|
|
264 |
|
|
Total other (expense) income, net |
|
|
(8,478 |
) |
|
|
(7,499 |
) |
|
|
100,402 |
|
|
|
(25,077 |
) |
|
(Loss) income before income taxes |
|
|
(29,225 |
) |
|
|
(47,420 |
) |
|
|
34,585 |
|
|
|
(129,455 |
) |
|
(Benefit) provision for income taxes |
|
|
(260 |
) |
|
|
— |
|
|
|
290 |
|
|
|
— |
|
|
Net (loss) income |
|
$ |
(28,965 |
) |
|
$ |
(47,420 |
) |
|
$ |
34,295 |
|
|
$ |
(129,455 |
) |
|
(Loss) earnings per common share, basic |
|
$ |
(3.13 |
) |
|
$ |
(5.62 |
) |
|
$ |
3.86 |
|
|
$ |
(16.68 |
) |
|
Weighted average common shares, basic |
|
|
9,261 |
|
|
|
8,444 |
|
|
|
8,877 |
|
|
|
7,762 |
|
|
(Loss) earnings per common share, diluted |
|
$ |
(3.13 |
) |
|
$ |
(5.62 |
) |
|
$ |
3.73 |
|
|
$ |
(16.68 |
) |
|
Weighted average common shares, diluted |
|
|
9,261 |
|
|
|
8,444 |
|
|
|
9,205 |
|
|
|
7,762 |
|
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Unaudited - in thousands)
|
|
|
Nine Months Ended September 30, |
|
|||||
|
|
|
2022 |
|
|
2021 |
|
||
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
34,295 |
|
|
$ |
(129,455 |
) |
|
Adjustments to reconcile net income (loss) to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
3,181 |
|
|
|
3,091 |
|
|
Charges to provision for doubtful accounts |
|
|
542 |
|
|
|
540 |
|
|
Inventory charge |
|
|
73 |
|
|
|
1,082 |
|
|
Debt financing fees |
|
|
20,053 |
|
|
|
4,158 |
|
|
Share-based compensation |
|
|
8,587 |
|
|
|
12,779 |
|
|
Gain on sale of business |
|
|
(143,384 |
) |
|
|
— |
|
|
Expense for accretion of Mandatory Redeemable Preferred Stock |
|
|
3,457 |
|
|
|
— |
|
|
Loss on extinguishment of debt |
|
|
8,380 |
|
|
|
— |
|
|
Other |
|
|
50 |
|
|
|
726 |
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
3,044 |
|
|
|
(5,560 |
) |
|
Inventory |
|
|
848 |
|
|
|
(451 |
) |
|
Prepaid and other current assets |
|
|
180 |
|
|
|
(2,831 |
) |
|
Accounts payable |
|
|
(6,186 |
) |
|
|
(1,476 |
) |
|
Accrued expenses and other current liabilities |
|
|
3,705 |
|
|
|
13,504 |
|
|
Other non-current liabilities |
|
|
(675 |
) |
|
|
758 |
|
|
Total adjustments |
|
|
(98,145 |
) |
|
|
26,320 |
|
|
Net cash used in operating activities |
|
|
(63,850 |
) |
|
|
(103,135 |
) |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
Proceeds from sale of business, net of transaction costs |
|
|
142,634 |
|
|
|
— |
|
|
Payment of patent related costs |
|
|
(297 |
) |
|
|
(675 |
) |
|
Purchase of fixed assets |
|
|
(21 |
) |
|
|
(34 |
) |
|
Net cash provided by (used in) investing activities |
|
|
142,316 |
|
|
|
(709 |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
Proceeds from sale of Mandatory Redeemable Preferred Stock, net of costs |
|
|
16,252 |
|
|
|
— |
|
|
Proceeds from make-whole derivative |
|
|
1,751 |
|
|
|
— |
|
|
Proceeds from sale of common stock, net of costs |
|
|
2,454 |
|
|
|
182,881 |
|
|
Proceeds from exercise of options and warrants |
|
|
— |
|
|
|
302 |
|
|
Proceeds from sale of common stock related to employee stock purchase plan |
|
|
14 |
|
|
|
134 |
|
|
Repayments of debt |
|
|
(125,000 |
) |
|
|
(50,000 |
) |
|
Payment of debt financing fees |
|
|
(729 |
) |
|
|
(5,118 |
) |
|
Net cash (used in) provided by financing activities |
|
|
(105,258 |
) |
|
|
128,199 |
|
|
Net (decrease) increase in cash and restricted cash |
|
|
(26,792 |
) |
|
|
24,355 |
|
|
Cash and restricted cash, beginning of period |
|
|
65,122 |
|
|
|
80,486 |
|
|
Cash and restricted cash, end of period |
|
$ |
38,330 |
|
|
$ |
104,841 |
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
8,371 |
|
|
$ |
19,675 |
|
|
Supplemental disclosure of noncash financing activities: |
|
|
|
|
|
|
|
|
|
Paid in kind ("PIK") interest with corresponding increase in debt |
|
$ |
2,452 |
|
|
$ |
— |
|
|
PIK debt financing fees with corresponding increase in debt |
|
$ |
16,980 |
|
|
$ |
— |
|
|
Issue of warrants to lenders related to debt financing fees |
|
$ |
1,983 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
CONTACT:
|
Michael C. Donegan |
Lisa M. Wilson |
|
Interim Chief Financial Officer, Chief Accounting Officer and Vice President Finance |
In-Site Communications, Inc. 212-452-2793 lwilson@insitecony.com |
|
561-961-1900 |
|