SAN DIEGO, March 4, 2021 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM), a commercial stage
biopharmaceutical company, today reported financial results for the
three- and twelve-month periods ended December 31, 2020.
"2020 was a year of execution for Evofem, marked by the
approval and U.S. commercial launch of Phexxi, our non-hormonal,
on-demand birth control method," said Saundra Pelletier, Chief Executive Officer,
Evofem Biosciences. "On Valentine's Day we launched our "Get
Phexxi" DTC campaign to propel the Phexxi uptake curve. I am
thrilled that in just two weeks we have seen a 362% increase in
direct searches for Phexxi."
"Additionally, we initiated our pivotal Phase 3 EVOGUARD
clinical trial evaluating the safety and efficacy of EVO100 for the
prevention of chlamydia and gonorrhea in women, for which reported
cases have increased significantly in five consecutive years. We
remain dedicated to developing products that address the unmet
medical needs of women."
Fourth Quarter and Recent Highlights include:
- "Get Phexxi" generated over 115 million views across all media
platforms in its first two weeks, leading to an increase in
consumer awareness of Phexxi and in telehealth activity;
- More than 2,650 healthcare providers have prescribed Phexxi
since launch;
- First quarter 2021 Phexxi unit shipments to wholesalers are on
track to exceed full-year 2020 levels;
- Launched collaboration with NCODA to educate oncology community
about Phexxi as a non-hormonal birth control option for women with
cancer; every year more than 800,000 new cases of cancer are
reported among women in the U.S.1;
- Commenced participation in Medicaid National Drug Rebate
Program for Phexxi on January 1,
2021;
- Listing of two Phexxi patents in the U.S. Food and Drug
Administration (FDA) publication Approved Drug Products with
Therapeutic Equivalence Evaluations, commonly known as the
Orange Book;
- Initiated the pivotal Phase 3 EVOGUARD study to evaluate safety
and efficacy of EVO100 for the prevention of chlamydia and
gonorrhea in women. EVOGUARD remains on track to complete
enrollment by the end of 2021; and,
- Secured a $25 million strategic
investment from Adjuvant Capital at a premium to market, with
proceeds earmarked to fund the pivotal EVOGUARD trial and expand
global market access for Phexxi.
Fourth Quarter Financial Results
The fourth quarter of
2020 was Evofem's first full quarter of product sales, following
the U.S. commercial launch of Phexxi on September 8, 2020 as the first and only
hormone-free, prescription vaginal gel approved for the prevention
of pregnancy. Gross revenues on the approximately 3,300 units
shipped in the fourth quarter were reduced by heavy utilization of
the Phexxi co-pay assistance program, as anticipated, coupled with
fixed costs primarily associated with distributor fees. As a result
of these gross-to-net adjustments, net product sales were
approximately $170,000.
Cost of goods sold was approximately $150,000 for the three months ended December 31, 2020.
Research and development costs were $5.9
million in the fourth quarter of 2020 versus $3.4 million in the prior year quarter. The
increase in the current period primarily reflects clinical trial
expenses for EVOGUARD, which was initiated in October 2020.
Selling and marketing costs were $23.9
million in the fourth quarter of 2020. For the fourth
quarter of 2019, selling and marketing costs of $4.0 million were reclassified from general and
administrative expenses to conform to the current period
presentation. The increased expense in the current period was
driven by the establishment of Evofem's sales organization in 2020
to support and execute the U.S. commercialization of Phexxi and
higher media and advertising related costs to drive healthcare
provider and consumer awareness and utilization.
General and administrative costs were $6.0 million in the fourth quarter of 2020 versus
$5.4 million in the prior year
quarter. The increase in costs is primarily associated with legal
and audit professional fees, offset by a decrease in noncash
stock-based compensation.
As a result, total operating expenses were $36.0 million for the quarter ended December 31, 2020, compared to $12.9 million for the quarter ended December 31, 2019.
Total other expense, net, was $4.7
million in the fourth quarter of 2020, and mainly included a
recorded change in fair value associated with the convertible notes
issued in the second quarter as a result of mark-to-market
adjustments, and accrued interest expense for the convertible notes
issued in the second and fourth quarters of 2020. This compares to
total other income, net, of $200,000
in the prior year quarter, which included higher interest income
than in the fourth quarter of 2020.
Net loss attributable to common stockholders was $40.6 million, or $(0.50) per share, for the fourth quarter of 2020
compared with a net loss of $12.7
million, or $(0.27) per share,
for the prior year quarter.
Full Year Financial Results
For the year ended
December 31, 2020, gross revenues on
the approximately 8,600 units shipped were reduced by heavy
utilization of the Phexxi copay assistance program, as anticipated,
coupled with fixed costs primarily associated with distributor
fees. As a result, net product sales were approximately
$450,000. There were no net
product sales in the prior year.
Cost of goods sold was approximately $470,000, which included a one-time charge of
approximately $100,000 predominantly
related to reworking the Phexxi product label to reflect the final
approved label.
Research and development costs were $17.1
million, in line with the Company's stated expectations,
compared to $22.2 million in the
prior year period. The decrease was primarily related to completion
of the clinical phases of the AMPOWER and AMPREVENCE studies,
offset by clinical trial expenses for EVOGUARD, which was initiated
in October 2020.
Selling and marketing costs were $56.5
million in 2020, below the Company's stated expectation of
$63 to $68
million primarily due to the timing of expense recognition,
reduced travel and lower payroll and related costs. For 2019,
selling and marketing costs of $10.2
million were reclassified from general and administrative
expenses to conform to the current period presentation. The
increased expense in the current period was driven by the
aforementioned expansion of Evofem's sales organization and
increased media and advertising costs in 2020.
General and administrative costs were $30.1 million, in line with the Company's stated
expectations, compared to $20.3
million in the prior year period. The increase was primarily
related to higher costs associated with legal, audit and financing
advisory fees, sales force recruiting costs, payroll related costs
due to increased headcount, noncash stock-based compensation, and
other general business expenses.
As a result, total operating expenses were $104.1 million for the year ended December 31, 2020, compared to total operating
expenses of $52.7 million for the
year ended December 31, 2019.
Total other expense of $38.7
million for the year ended December
31, 2020 was primarily attributable to noncash charges
related to the convertible notes issued during the second quarter
of 2020. Total other expense of $27.3
million in the year ended December
31, 2019 was primarily attributable to noncash charges
related to the closing of our private placement during the second
quarter of 2019 and to recognize various changes in the fair value
of warrants in the first quarter of 2019.
As a result, net loss attributable to common stockholders was
$142.3 million, or $(2.12) per share, for the year ended
December 31, 2020, compared with a
net loss of $80.0 million, or
$(1.99) per share, for the year ended
December 31, 2019.
Liquidity
In the fourth quarter of 2020, Evofem sold
$25 million of unsecured convertible
promissory notes to funds affiliated with Adjuvant Capital, LP
("Adjuvant Capital"). The notes are convertible into shares of
Evofem common stock at a conversion price of $3.65 per share. Proceeds support EVOGUARD,
Evofem's ongoing Phase 3 clinical trial of EVO100 for the
prevention of urogenital chlamydia and gonorrhea in women, and
expanding global market access for Phexxi.
At December 31, 2020, the Company
had $48.9 million of unrestricted
cash and $22.6 million of restricted
cash, as compared to $86.7 million of
unrestricted cash and $0.3 million of
restricted cash at September 30,
2020.
Conference Call
As previously announced, the Evofem
management team will host a conference call to discuss its
financial results and business highlights as follows:
Date
|
Thursday March 4,
2021
|
Time
|
4:30 p.m. ET (1:30
p.m. PT)
|
Webcast (live and
archived)
|
https://evofem.investorroom.com/Q4YE2020Results
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
9928997
|
Please connect to the Company's website at least 15 minutes
prior to the start of the event to download any software that may
be required. If participating by phone, please also dial in
approximately 15 minutes prior to the start of the call.
The webcast will be archived at
https://evofem.investorroom.com/Q4YE2020Results. A telephone replay
will be available for 24 hours after the call at (855) 859-2056
(U.S.) or (404) 537-3406 (International), conference ID
9928997.
About Evofem Biosciences
Evofem Biosciences, Inc.,
(NASDAQ: EVFM) is a commercial-stage biopharmaceutical company
committed to developing and commercializing innovative products to
address unmet needs in women's sexual and reproductive health,
including hormone-free, woman-controlled contraception and
protection from certain sexually transmitted infections (STIs). The
Company's first commercial product, Phexxi®, is the first and only
hormone-free, prescription vaginal gel approved in the United States for the prevention of
pregnancy. The Company's lead product candidate, EVO100, is being
evaluated for the prevention of urogenital Chlamydia
trachomatis and Neisseria gonorrhoeae infection in women
in the ongoing Phase 3 clinical trial, 'EVOGUARD.' For more
information, please visit www.evofem.com.
Phexxi® is a registered trademark of Evofem Biosciences,
Inc.
About PHEXXI®
Phexxi® is an on-demand method of birth
control used to prevent pregnancy. Phexxi® is not effective when
used after sex.
IMPORTANT SAFETY INFORMATION
- If you have had a history of repeated urinary tract infections
or other urinary tract problems, avoid Phexxi®.
- The most common side effects were vaginal burning, vaginal
itching, vaginal yeast infection, urinary tract infection, vaginal
area discomfort, bacterial vaginosis, vaginal discharge, genital
discomfort (including male partners), and pain while
urinating.
- Phexxi® does not protect against any sexually transmitted
infections, including HIV.
- Contact your healthcare provider if you are experiencing severe
genital irritation or discomfort or urinary tract symptoms.
For more information about Phexxi®, talk to your healthcare
provider and see full Product Information at
https://www.phexxi.com/themes/custom/phexxiDTC/dist/pdf/PhexxiUSPI.pdf.
Please report side effects by contacting Evofem Biosciences®
toll-free at 1-833-EVFMBIO or contact FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Forward-Looking Statements
This press release includes
"forward-looking statements," within the meaning of the safe harbor
for forward-looking statements provided by Section 21E of the
Securities Exchange Act of 1934, as amended, and the Private
Securities Litigation Reform Act of 1995 including, without
limitation, statements related to the expected impact of the "Get
Phexxi" campaign on consumer behavior, month over month
prescription growth, brand awareness and uptake, and future growth
of sales of Phexxi and the Company generally. Various factors could
cause actual results to differ materially from those discussed or
implied in the forward-looking statements, and you are cautioned
not to place undue reliance on these forward-looking statements,
which are current only as of the date of this press release. Each
of these forward- looking statements involves risks and
uncertainties. Important factors that could cause actual results to
differ materially from those discussed or implied in the
forward-looking statements, or that could impair the value of
Evofem Biosciences' assets and business, are disclosed in the
Company's SEC filings, including its Annual Report on Form 10-K for
the year ended December 31, 2020
filed with the SEC on March 4, 2021.
All forward-looking statements are expressly qualified in their
entirety by such factors. The Company does not undertake any duty
to update any forward-looking statement except as required by law.
This press release contains estimates and other statistical data
made by independent parties and by the Company relating to market
size and growth and other data about its industry. This data
involves a number of assumptions and limitations, and you are
cautioned not to give undue weight to such estimates.
References
1 U.S. Cancer Statistics:
Highlights from 2017 Incidence. U.S. Cancer Statistics Data Briefs,
No. 17, June 2020.
https://www.cdc.gov/cancer/uscs/about/data-briefs/no17-USCS-highlights-2017-incidence.htm
Investor Contact
Amy
Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
Media Contact
Ellen
Thomas
Evofem Biosciences, Inc.
ethomas@evofem.com
Mobile: (718) 490-3248
(Tables follow)
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED BALANCE SHEET DATA
|
(Unaudited)
|
(In
thousands)
|
|
|
December 31,
2020
|
|
December 31,
2019
|
Cash and cash
equivalents
|
$
|
48,892
|
|
|
$
|
15,571
|
|
Restricted
cash
|
22,559
|
|
|
304
|
|
Short-term
investments
|
—
|
|
|
8,233
|
|
Trade accounts
receivable, net
|
1,067
|
|
|
—
|
|
Total current
liabilities
|
77,283
|
|
|
12,659
|
|
Total
liabilities
|
108,621
|
|
|
12,659
|
|
Total stockholders'
equity
|
1,347
|
|
|
15,636
|
|
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
(In thousands, except
share and per share data)
|
|
|
Quarter Ended
December 31,
|
|
Year Ended
December 31,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Product sales,
net
|
$
|
168
|
|
|
$
|
—
|
|
|
$
|
446
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods
sold
|
151
|
|
|
—
|
|
|
468
|
|
|
—
|
|
Research and
development
|
5,946
|
|
|
3,432
|
|
|
17,050
|
|
|
22,230
|
|
Selling and
marketing
|
23,914
|
|
|
4,016
|
|
|
56,467
|
|
|
10,238
|
|
General and
administrative
|
6,008
|
|
|
5,424
|
|
|
30,085
|
|
|
20,274
|
|
Total operating
expenses
|
36,019
|
|
|
12,872
|
|
|
104,070
|
|
|
52,742
|
|
Loss from
operations
|
(35,851)
|
|
|
(12,872)
|
|
|
(103,624)
|
|
|
(52,742)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
17
|
|
|
120
|
|
|
169
|
|
|
458
|
|
Other (expense)
income
|
(1,072)
|
|
|
35
|
|
|
(2,082)
|
|
|
301
|
|
Loss on issuance of
financial instruments
|
—
|
|
|
—
|
|
|
(64,049)
|
|
|
(674)
|
|
Change in fair value
of financial instruments
|
(3,690)
|
|
|
—
|
|
|
27,281
|
|
|
(27,372)
|
|
Total other (expense)
income, net
|
(4,745)
|
|
|
155
|
|
|
(38,681)
|
|
|
(27,287)
|
|
Loss before income
tax
|
(40,596)
|
|
|
(12,717)
|
|
|
(142,305)
|
|
|
(80,029)
|
|
Income tax
expense
|
(2)
|
|
|
—
|
|
|
(4)
|
|
|
(4)
|
|
Net loss
|
(40,598)
|
|
|
(12,717)
|
|
|
(142,309)
|
|
|
(80,033)
|
|
Net loss per share,
basic and diluted
|
$
|
(0.50)
|
|
|
$
|
(0.27)
|
|
|
$
|
(2.12)
|
|
|
$
|
(1.99)
|
|
Weighted-average
shares used to compute net loss per
share, basic and diluted
|
81,221,603
|
|
|
47,443,632
|
|
|
67,157,278
|
|
|
40,228,517
|
|
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SOURCE Evofem Biosciences, Inc.