SAN DIEGO, Aug. 4, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"), a
commercial stage biopharmaceutical company, today reported
financial results for the three- and six- month periods ended
June 30, 2020.
"The second quarter of 2020 was marked by success across all
areas of our business. With the FDA approval of Phexxi in hand,
more than $130 million in gross
proceeds from our two financing transactions on the books, and
clear guidance from the FDA regarding the clinical path forward for
EVO100, we are operating from a position of strength with a clear
vision for the future," said Saundra
Pelletier, Evofem's Chief Executive Officer. "We are
now intensely focused on the successful commercial launch of Phexxi
in September and ensuring the team's ongoing excellence in
execution with manufacturing timelines, payer coverage, sales force
recruitment and the build-out of our unique telemedicine
platform — the Phexxi Concierge Experience.
It's going to be an exciting third quarter."
Second quarter and recent highlights include:
- Received U.S. Food and Drug Administration (FDA) approval of
Phexxi™ (lactic acid, citric acid and potassium bitartrate) for the
prevention of pregnancy in females of reproductive potential for
use as an on-demand method of contraception;
- Strengthened the balance sheet with approximately $136 million in gross proceeds from two financing
transactions during an incredibly challenging time in the financial
markets;
- Both Medi-Span and First Databank, the two major drug
information compendiums where the majority of payers obtain pricing
and product information, have granted Phexxi new classification in
their databases and pricing compendia as the first and only
"Vaginal pH Modulator";
- Met with all major commercial payers and garnered early
formulary inclusion of Phexxi at $0
copay from several regional insurers;
- Ongoing publication and presentation of data from the Phase 3
AMPOWER study of Phexxi for prevention of pregnancy, including
peer-reviewed publication of the pivotal AMPOWER study results in
Contraception; and,
- Participated in a productive End-of-Phase 2 meeting with the
FDA, which supported and informed the Company's pivotal Phase 3
clinical trial design for EVO100 for the prevention of urogenital
chlamydia and gonorrhea in women; study to be initiated in the
fourth quarter of 2020.
Financial Results
Total operating expenses were
$22.4 million for the quarter ended
June 30, 2020, compared to
$11.9 million for the quarter ended
June 30, 2019.
Research and development costs for the second quarter of 2020
were $2.6 million, compared to
$5.2 million in the prior year
quarter, reflecting a $2.3 million
decrease in clinical trial costs due to completion of the
AMPREVENCE trial in the fourth quarter of 2019. Additionally,
an aggregate $1 million
reduction in outside services cost and payroll related expense was
partially offset by a $500,000
increase in noncash stock-based compensation in the current
period.
Selling and marketing costs for the second quarter of 2020
were $10.0 million. For the second quarter of 2019,
selling and marketing costs of $1.3
million were reclassified from general and administrative
expenses to conform to the current period presentation.
The increased expense in the current period reflects
preparations for the commercial launch of Phexxi for the prevention
of pregnancy in September 2020,
including increased pre-commercialization marketing expenses,
higher payroll-related expenses due to increased headcount, and
increased market access and medical affairs expenses.
General and administrative costs for the second quarter of 2020
were $9.7 million, compared to
$5.4 million in the prior year
quarter. The increase is primarily related to an aggregate
$2.1 million increase in costs
associated with various operational items associated with the
issuance of convertible debt, legal costs, payroll related costs
due to increased headcount, and other general business expenses.
Additionally, there was a $2.2
million increase in noncash stock-based compensation mainly
associated with stock-based awards granted in February 2020.
Total other expense was $30.3
million in the second quarter of 2020, and mainly included
the noncash loss on the issuance and subsequent change in fair
value during the period of convertible notes, warrants, and
purchase rights that were issued in connection with the debt
transaction that closed during the second quarter of 2020. Total
other expense of $23.5 million in the
prior year quarter included noncash charges associated with the
$80 million private placement that
closed during that period.
As a result, net loss attributable to common stockholders was
$52.7 million, or $(0.91) per share, for the quarter ended
June 30, 2020, compared with a net
loss of $35.5 million, or
$(0.97) per share, for the prior year
quarter.
Unrestricted cash and short-term investments were $123.6 million at June 30,
2020, compared to $23.8
million at December 31,
2019.
The Company reiterated its prior guidance for fiscal 2020,
including its expectations of:
- General and administrative expense in the upper $20 million to low $30
million range, including approximately $8 to $10 million
of noncash stock-based compensation expense;
- Research and development expense in the high-teens to low
$20 million range, including
anticipated noncash stock-based compensation expense of
$2 to $3
million.
- Sales and marketing expenses of approximately $63 to $68 million,
including anticipated noncash stock-based compensation expense of
$2.5 million.
The Company continues to expect cash burn of approximately
$36 to $38
million in the third quarter and approximately $42 to $44 million
in the fourth quarter of 2020. Based on current forecasts, the
Company believes its current cash and short-term investments
provide runway into the second quarter of 2021.
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
|
August 4,
2020
|
Time
|
11:00 a.m. EDT
(8:00am PDT)
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
5884198
|
Webcast (live and
archived)
|
www.evofem.com under
"Investors" or click here
|
The live webcast and related slide presentation can be accessed
on the Company's Investor page
at https://evofem.investorroom.com/events. Please connect to
the Company's website at least 15 minutes prior to the start of the
call to download any software that may be required. If
participating by phone, please dial in approximately 10 minutes
prior to the start of the call.
A telephone replay will be available approximately two hours
after the call through Friday, August 7, 2020 at (855)
859-2056 (U.S.) or (404) 537-3406 (International), conference
ID 5884198. The webcast will be archived
at https://evofem.investorroom.com/events.
About PHEXXI™ (lactic acid, citric acid, and potassium
bitartrate) Vaginal Gel
Phexxi is a prescription vaginal
gel used to prevent pregnancy in females who choose to use an
on-demand method of birth control. Phexxi is only effective when
used immediately before (or up to one hour before) each act
of vaginal sex. It is not effective when used after vaginal
sex.
Important Safety Information
What are the possible
side effects of Phexxi?
There have been a few cases of
urinary bladder infection and kidney infection reported in clinical
studies. One of the cases was serious. Avoid Phexxi if you have had
repeated urinary tract infections or other urinary tract
problems.
The most common side effects were vaginal burning,
vaginal itching, vaginal yeast infection, urinary tract infection,
vaginal area discomfort, bacterial vaginosis, and vaginal
discharge. Women also reported genital discomfort, pain while
urinating, and vaginal pain. Some male partners reported genital
discomfort.
What else should I know about using Phexxi?
Phexxi
does not protect against any sexually transmitted diseases,
including HIV. Avoid using Phexxi with a vaginal ring.
Contact your healthcare provider if you are experiencing severe
genital irritation or discomfort or urinary tract symptoms. Avoid
Phexxi if you or your sexual partner is allergic to lactic acid,
citric acid, potassium bitartrate, or any of the ingredients in
Phexxi. Stop using Phexxi if you develop an allergic reaction.
Please see full Prescribing Information for Phexxi, including
Patient Information.
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.
About Evofem Biosciences, Inc.
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™ (lactic acid, citric
acid and potassium bitartrate), is the first and only hormone-free,
prescription gel approved in the United
States for the prevention of pregnancy. The Company is also
advancing EVO100 into Phase 3 clinical trials for the prevention of
urogenital transmission of both Chlamydia trachomatis
infection (chlamydia) and Neisseria gonorrhoeae infection
(gonorrhea) in women. For more information, please visit
www.evofem.com.
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 Evofem's expectations regarding
its burn rate and cash runway, the success and timing of the
commercial launch of Phexxi, the success of the Phexxi Concierge
Experience, the execution and success of our publication and
presentation plan, and the timing of our Phase 3 clinical trial for
EVO100. 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 Evofem's SEC filings, including its Annual Report
on Form 10-K for the year ended December 31, 2019 filed
with the SEC on March 12, 2020, its Quarterly Report on Form
10-Q for the quarters ended March 31, and June 30, 2020 filed with the SEC on May
6, 2020 and August 4, 2020,
respectively, and its Current Report on Form 8-K filed with the SEC
on June 2, 2020. All forward-looking statements are expressly
qualified in their entirety by such factors. Evofem does not
undertake any duty to update any forward-looking statement except
as required by law.
Phexxi™ is a trademark of Evofem Biosciences.
Contact
Investor Relations
Amy Raskopf
Evofem Biosciences
araskopf@evofem.com
O: (858) 550-1900 x167
M: (917) 673-5775
Media
Cara Miller
Evofem Biosciences
cmiller@evofem.com
O: (858) 550-1900 x272
(Tables follow)
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In
thousands)
|
|
|
June 30,
2020
|
|
December 31,
2019
|
Cash and cash
equivalents
|
$
|
123,556
|
|
|
$
|
15,571
|
|
Restricted
cash
|
200
|
|
|
304
|
|
Short-term
investments
|
—
|
|
|
8,233
|
|
Total current
liabilities
|
61,806
|
|
|
12,659
|
|
Total
liabilities
|
66,517
|
|
|
12,659
|
|
Total stockholders'
equity
|
68,539
|
|
|
15,636
|
|
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except
share and per share data)
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
|
2,640
|
|
|
$
|
5,246
|
|
|
$
|
6,887
|
|
|
$
|
13,135
|
|
Selling and
marketing
|
9,997
|
|
|
1,313
|
|
|
17,852
|
|
|
2,431
|
|
General and
administrative
|
9,735
|
|
|
5,382
|
|
|
16,877
|
|
|
10,007
|
|
Total operating
expenses
|
22,372
|
|
|
11,941
|
|
|
41,616
|
|
|
25,573
|
|
Loss from
operations
|
(22,372)
|
|
|
(11,941)
|
|
|
(41,616)
|
|
|
(25,573)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
29
|
|
|
108
|
|
|
131
|
|
|
126
|
|
Other
expense
|
(349)
|
|
|
(7)
|
|
|
(353)
|
|
|
(21)
|
|
Loss on issuance of
financial instruments
|
(64,049)
|
|
|
(674)
|
|
|
(64,049)
|
|
|
(674)
|
|
Change in fair value
of financial instruments
|
34,075
|
|
|
(22,932)
|
|
|
34,075
|
|
|
(27,372)
|
|
Total other expense,
net
|
(30,294)
|
|
|
(23,505)
|
|
|
(30,196)
|
|
|
(27,941)
|
|
Loss before income
tax
|
(52,666)
|
|
|
(35,446)
|
|
|
(71,812)
|
|
|
(53,514)
|
|
Income tax
expense
|
—
|
|
|
(4)
|
|
|
—
|
|
|
(4)
|
|
Net loss
|
(52,666)
|
|
|
(35,450)
|
|
|
(71,812)
|
|
|
(53,518)
|
|
Net loss per share,
basic and diluted
|
(0.91)
|
|
|
(0.97)
|
|
|
(1.36)
|
|
|
(1.68)
|
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
57,696,519
|
|
|
36,732,568
|
|
|
52,946,235
|
|
|
31,941,850
|
|
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SOURCE Evofem Biosciences, Inc.