Significant growth in net revenue, net revenue per unit and prescriptions across product portfolio
Total net revenue increased 80% to
ANNOVERA® net revenue increased 250% for 3Q20 compared to 2Q20
Menopausal products achieved double digit growth in new and total prescriptions for 3Q20 compared to 2Q20
Reduced 3Q20 cash burn by
Process to divest vitaCare Prescription Services underway that could generate non-dilutive proceeds
Conference call scheduled for
“We delivered a strong quarter that resulted in record growth across our product portfolio in the midst of a pandemic and beat net revenue consensus estimates for the sixth quarter in a row,” said
Third Quarter 2020 Summary
- Total net revenue increased 80% to
$19.3 million for the third quarter of 2020 as compared to$10.7 million for the second quarter of 2020.- Product net revenue from product sales to wholesalers and pharmacies increased 62% to
$17.3 million for the third quarter of 2020 as compared to$10.7 million for the second quarter of 2020. - License revenue of
$2 million from Knight Therapeutics, Inc. was recognized in the third quarter of 2020 as a result the approval byHealth Canada of IMVEXXY and BIJUVA® for commercial sale inCanada .
- Product net revenue from product sales to wholesalers and pharmacies increased 62% to
- Total operating expenses, excluding non-cash items, decreased by
$11.0 million to$37.1 million for the third quarter of 2020 as compared to$48.1 million for the second quarter of 2020.
ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system)
- ANNOVERA net product revenue increased 250% to
$6.4 million for the third quarter of 2020 as compared to$1.8 million for the second quarter of 2020. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was$1,339 for the third quarter of 2020. - Approximately 5,200 ANNOVERA prescriptions were dispensed during the third quarter of 2020. ANNOVERA total prescription volume increased 115% for third quarter of 2020 as compared to the second quarter of 2020.
- ANNOVERA gained preferred coverage with one of the top pharmaceutical benefit managers (PBM), representing approximately 20% of commercial lives, effective in the first quarter of 2021.
- This PBM will include ANNOVERA as the only preferred branded contraceptive vaginal ring agent and will remove NuvaRing® from its 2021 formulary.
- ANNOVERA was added by
Medi-Cal as ofNovember 1, 2020 and will be fully implemented across allCalifornia lives (approximately 16% of national Medicaid population) byJanuary 1, 2020 .
IMVEXXY® (estradiol vaginal inserts)
- IMVEXXY net product revenue increased 35% to
$6.8 million for the third quarter of 2020 as compared to$5.1 million for the second quarter of 2020. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was$51 for the third quarter of 2020. Strong IMVEXXY refill rates continued with patients adhering to therapy. - Approximately 131,000 IMVEXXY prescriptions were dispensed during the third quarter of 2020. IMVEXXY new prescription volume increased 32% for third quarter of 2020 as compared to the second quarter of 2020, which should positively impact total prescriptions going forward. IMVEXXY total prescriptions increased 11% for same period.
- IMVEXXY gained preferred coverage with one of the top PBMs, representing approximately 20% of commercial lives, effective in the first quarter of 2021.
- This PBM will include IMVEXXY as the only branded pharmaceutical product on formulary for the vulvar and vaginal atrophy (VVA) class and will remove Premarin® Cream, Intrarosa®, Osphena® and Estring® from the 2021 formulary.
BIJUVA® (estradiol and progesterone)
- BIJUVA net product revenue increased 22% to
$1.6 million for the third quarter of 2020 as compared to$1.4 million the second quarter of 2020. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was$47 for the third quarter of 2020. - Approximately 32,000 BIJUVA prescriptions were dispensed in the third quarter of 2020. BIJUVA new prescription volume increased approximately 59% for the third quarter of 2020 as compared to the second quarter of 2020. Total prescriptions increased approximately 16% during the same period.
- Anthem (includes many
Blue Cross Blue Shield plans) moved BIJUVA from non-preferred to preferred formulary status as ofOctober 1 , 2020.
Net Revenue
|
|
Three Months Ended |
|
Three Months Ended |
|
Three Months Ended |
|||
|
|
|
|||||||
ANNOVERA |
|
$ |
6,418,990 |
|
$ |
399,952 |
|
|
|
IMVEXXY |
|
|
6,841,592 |
|
|
4,772,354 |
|
|
5,085,190 |
BIJUVA |
|
|
1,646,320 |
|
|
490,705 |
|
|
1,352,001 |
Prenatal vitamins |
|
|
2,435,903 |
|
|
2,550,330 |
|
|
2,428,382 |
Licensing revenue |
|
2,000,000 |
|
|
15,506,400 |
|
|
- |
|
Net revenue |
|
$ |
19,342,805 |
|
$ |
23,719,741 |
|
$ |
10,701,033 |
Cost of Goods Sold/Gross Margin
- Cost of goods sold decreased
$1.1 million to$3.3 million for the third quarter of 2020 compared to$4.4 million for the second quarter of 2020.- The second quarter of 2020 included a non-cash write-off of
$1.9 million primarily related to BIJUVA inventory obsolescence as a result of the Company’s reprioritization of selling resources to ANNOVERA and IMVEXXY, together with the impact of the COVID-19 pandemic on sales forecasts of BIJUVA for future quarters, which was partially offset by the increase in cost of goods related to increased unit sales for the quarter. - Gross margin percentage increased to 83% for quarter ended
September 30, 2020 inclusive of the license revenue of$2 million (81% when excluding license revenue), as compared to 59% for the quarter endedJune 30, 2020 , which was impacted by the non-cash write-off of$1.9 million .
- The second quarter of 2020 included a non-cash write-off of
Expense, EPS and Related Information
- Total operating expenses, excluding non-cash items, decreased by
$11.0 million to$37.1 million for the third quarter of 2020 as compared to$48.1 million for the second quarter of 2020.- The decrease in operating expenses was primarily a result of the Company’s cost containment efforts to reduce overall spend.
- For the remainder of 2020, the Company anticipates that 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.
- Net loss for the quarter ended
September 30, 2020 decreased to$32.6 million , or$0.12 per basic and diluted share, compared with$52.0 million , or$0.19 per basic and diluted share, for the quarter endedJune 30, 2020 .- Net loss per share for the second quarter of 2020 was negatively impacted by inventory and sample expense charges related primarily to BIJUVA of
$0.02 per basic and diluted share.
- Net loss per share for the second quarter of 2020 was negatively impacted by inventory and sample expense charges related primarily to BIJUVA of
Balance Sheet
- As of
September 30, 2020 , the Company’s cash on hand totaled$79.6 million , compared with$113.8 million as ofJune 30, 2020 .
Potential vitaCare Divesture
Sixth Street Update
The Company entered into an agreement with its lender,
Conference Call and Webcast Details
Date: |
|
|
Time: |
|
|
Telephone Access (US): |
|
866-665-9531 |
Telephone Access (International): |
|
724-987-6977 |
Access Code for All Callers: |
|
7747227 |
A live webcast and audio archive for the event may be accessed on the home page or from the “Investors & Media” section of the
Please see the Full Prescribing Information, including indication and Boxed WARNING, for each
- 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
Forward-Looking Statements
This press release by
CONSOLIDATED BALANCE SHEETS | |||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current Assets: | |||||||
Cash |
$ |
79,633,675 |
|
$ |
160,829,713 |
|
|
Accounts receivable, net of allowance for doubtful accounts of |
24,059,095 | 24,395,958 | |||||
Inventory, net |
|
9,932,304 |
|
|
11,860,716 |
|
|
Other current assets |
|
8,819,239 |
|
|
11,329,793 |
|
|
Total current assets |
|
122,444,313 |
|
|
208,416,180 |
|
|
Fixed assets, net |
|
1,969,929 |
|
|
2,507,775 |
|
|
Other Assets: | |||||||
License rights, net |
|
36,959,305 |
|
|
39,221,308 |
|
|
Intangible assets, net |
|
5,537,885 |
|
|
5,258,211 |
|
|
Right of use assets |
|
9,975,725 |
|
|
10,109,154 |
|
|
Other assets |
403,643 |
473,009 |
|||||
Total other assets |
|
52,876,558 |
|
|
55,061,682 |
|
|
Total assets |
$ |
177,290,800 |
|
$ |
265,985,637 |
|
|
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | |||||||
Current Liabilities: | |||||||
Accounts payable |
$ |
16,109,638 |
|
$ |
19,181,212 |
|
|
Other current liabilities |
|
31,220,484 |
|
|
33,823,613 |
|
|
Total current liabilities |
|
47,330,122 |
|
|
53,004,825 |
|
|
Long-Term Liabilities: | |||||||
Long-term debt |
|
237,051,202 |
|
|
194,634,643 |
|
|
Operating lease liability |
|
8,907,995 |
|
|
9,145,049 |
|
|
Other long-term liabilities |
|
35,000 |
|
|
- |
|
|
Total long-term liabilities |
|
245,994,197 |
|
|
203,779,692 |
|
|
Total liabilities |
|
293,324,319 |
|
|
256,784,517 |
|
|
Commitments and Contingencies | |||||||
Stockholders' Equity: | |||||||
Preferred stock - par value |
- | - | |||||
Common stock - par value |
272,812 | 271,177 | |||||
Additional paid-in capital |
|
720,551,488 |
|
|
704,351,222 |
|
|
Accumulated deficit |
|
(836,857,819 |
) |
|
(695,421,279 |
) |
|
Total stockholders' (deficit) equity |
|
(116,033,519 |
) |
|
9,201,120 |
|
|
Total liabilities and stockholders' (deficit) equity |
$ |
177,290,800 |
|
$ |
265,985,637 |
|
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||
(Unaudited) | |||||||||||||||||||
Three Months Ended | Three Months ended | Nine Months Ended | |||||||||||||||||
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2020 |
|
|
2019 |
|
|||||
Product revenue, net |
$ |
17,342,805 |
|
$ |
8,213,341 |
|
$ |
10,701,033 |
|
$ |
40,294,495 |
|
$ |
18,238,857 |
|
||||
License revenue |
|
2,000,000 |
|
|
15,506,400 |
|
|
- |
|
|
2,000,000 |
|
|
15,506,400 |
|
||||
Total revenue, net |
|
19,342,805 |
|
|
23,719,741 |
|
|
10,701,033 |
|
|
42,294,495 |
|
|
33,745,257 |
|
||||
Cost of goods sold |
|
3,278,609 |
|
|
1,444,308 |
|
|
4,400,485 |
|
|
10,394,145 |
|
|
3,455,995 |
|
||||
Gross profit |
|
16,064,196 |
|
|
22,275,433 |
|
|
6,300,548 |
|
|
31,900,350 |
|
|
30,289,262 |
|
||||
Operating expenses: | |||||||||||||||||||
Sales, general, and administrative |
|
38,751,250 |
|
|
45,126,986 |
|
|
48,340,628 |
|
|
144,018,899 |
|
|
121,378,519 |
|
||||
Research and development |
|
2,027,195 |
|
|
4,077,738 |
|
|
2,742,032 |
|
|
8,038,056 |
|
|
15,359,988 |
|
||||
Depreciation and amortization |
|
258,787 |
|
|
141,959 |
|
|
256,557 |
|
|
777,338 |
|
|
363,956 |
|
||||
Total operating expenses |
|
41,037,232 |
|
|
49,346,683 |
|
|
51,339,217 |
|
|
152,834,293 |
|
|
137,102,463 |
|
||||
Operating loss |
|
(24,973,036 |
) |
|
(27,071,250 |
) |
|
(45,038,669 |
) |
|
(120,933,943 |
) |
|
(106,813,201 |
) |
||||
Other (expense) income | |||||||||||||||||||
Loss on extinguishment of debt |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(10,057,632 |
) |
||||
Miscellaneous income |
|
41,405 |
|
|
703,662 |
|
|
88,858 |
|
|
465,745 |
|
|
1,878,980 |
|
||||
Interest expense |
|
(7,679,443 |
) |
|
(5,599,005 |
) |
|
(7,026,853 |
) |
|
(20,968,342 |
) |
|
(11,717,632 |
) |
||||
Total other expense, net |
|
(7,638,038 |
) |
|
(4,895,343 |
) |
|
(6,937,995 |
) |
|
(20,502,597 |
) |
|
(19,896,284 |
) |
||||
Loss before income taxes |
|
(32,611,074 |
) |
|
(31,966,593 |
) |
|
(51,976,664 |
) |
|
(141,436,540 |
) |
|
(126,709,485 |
) |
||||
Provision for income taxes |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
||||
Net loss |
$ |
(32,611,074 |
) |
$ |
(31,966,593 |
) |
$ |
(51,976,664 |
) |
$ |
(141,436,540 |
) |
$ |
(126,709,485 |
) |
||||
Loss per share, basic and diluted: | |||||||||||||||||||
Net loss per share, basic and diluted |
$ |
(0.12 |
) |
$ |
(0.13 |
) |
$ |
(0.19 |
) |
$ |
(0.52 |
) |
$ |
(0.53 |
) |
||||
Weighted average number of common shares outstanding, basic and diluted |
|
272,564,635 |
|
|
241,261,299 |
|
|
271,876,238 |
|
|
271,968,981 |
|
|
241,163,994 |
|
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
(Unaudited) | |||||||
Nine Months Ended | |||||||
|
2020 |
|
|
2019 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
Net loss |
$ |
(141,436,540 |
) |
$ |
(126,709,485 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation of fixed assets |
|
576,459 |
|
|
223,750 |
|
|
Amortization of intangible assets |
|
200,879 |
|
|
140,206 |
|
|
Write off of patent and trademark costs |
|
584,509 |
|
|
78,864 |
|
|
Write off of deferred financing fees |
|
275,379 |
|
|
- |
|
|
Non-cash operating lease expense |
|
1,050,940 |
|
|
711,836 |
|
|
(Recovery of) provision for doubtful accounts |
|
(46,864 |
) |
|
95,097 |
|
|
Lease impairment |
|
81,309 |
|
|
- |
|
|
Inventory obsolesence reserve |
|
5,744,464 |
|
|
- |
|
|
Loss on extinguishment of debt |
|
- |
|
|
10,057,632 |
|
|
Share-based compensation |
|
8,502,044 |
|
|
7,859,357 |
|
|
Amortization of intellectual property license fee |
|
2,262,002 |
|
|
15,998 |
|
|
Amortization of deferred financing fees |
|
1,370,118 |
|
|
582,829 |
|
|
Changes in operating assets and liabilities: | |||||||
Accounts receivable |
|
383,727 |
|
|
(4,354,890 |
) |
|
Inventory |
|
(3,816,053 |
) |
|
(7,265,174 |
) |
|
Other assets |
|
2,003,079 |
|
|
(1,128,515 |
) |
|
Accounts payable |
|
(3,071,574 |
) |
|
1,389,665 |
|
|
Accrued expenses and other current liabilities |
|
(3,812,919 |
) |
|
3,402,511 |
|
|
Net cash used in operating activities |
|
(129,149,041 |
) |
|
(114,900,319 |
) |
|
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||
Patent costs |
|
(1,065,062 |
) |
|
(1,068,542 |
) |
|
Purchase of fixed assets |
|
(38,613 |
) |
|
(2,089,413 |
) |
|
Security deposit |
|
35,000 |
|
|
(20,420 |
) |
|
Net cash used in investing activities |
|
(1,068,675 |
) |
|
(3,178,375 |
) |
|
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||
Proceeds from exercise of options and warrants |
|
271,678 |
|
|
108,656 |
|
|
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 |
|
49,021,678 |
|
|
111,795,667 |
|
|
Decrease in cash |
|
(81,196,038 |
) |
|
(6,283,027 |
) |
|
Cash, beginning of period |
|
160,829,713 |
|
|
161,613,077 |
|
|
Cash, end of period |
$ |
79,633,675 |
|
$ |
155,330,050 |
|
|
Supplemental disclosure of noncash investing and financing activities | |||||||
Warrant granted in relation to Financing Agreement |
$ |
7,428,179 |
|
$ |
- |
|
|
Amount accrued for intellectual property license |
$ |
- |
|
$ |
20,000,000 |
|
|
Supplemental disclosure of cash flow information | |||||||
Interest paid |
$ |
19,172,847 |
|
$ |
12,446,792 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20201109005481/en/
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
Source: