SOUTH SAN FRANCISCO, Calif.,
March 30, 2020 /PRNewswire/ -- Titan
Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company")
today reported financial results for the fourth quarter and full
year ended December 31, 2019 and
provided an update on its business.
Full Year 2019 Business Highlights
- In early 2019, Titan reported completion of the initial
activities planned for the reacquisition of Probuphine®
(buprenorphine) implant, Titan's novel six-month maintenance
treatment for opioid use disorder ("OUD") in eligible
patients, from its former licensee. This included the
recruitment and onboarding of a small number of highly qualified
commercial and medical affairs personnel to reengage with health
care providers who had previously treated patients with Probuphine,
providing retraining and medical liaison assistance where needed,
and assuring the medical community of the continued supply of the
product with the goal to stabilize Probuphine usage.
- A key objective for Titan in the first half of 2019 was to
improve the overall commercial services provided to the health care
providers and patients through streamlining the product
distribution and third party payor reimbursement process. This was
accomplished through the following steps that were completed by
August 2019:
-
- Entering into an agreement with AppianRx to establish a new
'hub' that provides a full suite of patient and healthcare provider
support services related to Probuphine, including an improved
product ordering system and performing REMS required verification
steps, and initial assessment of third party payor benefits
available to the patient.
- Establishing specialty pharmacy distribution and services
agreements for Probuphine with a number of well recognized
companies, including AllianceRx Walgreens Prime, Accredo® specialty
pharmacy (a subsidiary of Express Scripts), CVS Caremark (a
subsidiary of CVS Health) and Southside Specialty Pharmacy, with
the goal to improve third party payor access and improve product
distribution.
- Also in the first half of 2019, Titan and Molteni & C. dei
F.lli Alitti Società di Esercizio S.p.A. ("Molteni"), Titan's
Probuphine partner for Europe and
certain other territories, worked closely to meet with the
Committee for Medicinal Products for Human Use of the European
Medicines Agency and address all their questions regarding
Sixmo®-buprenorphine (the brand name for Probuphine
implant in the European Union) which led to the adoption of a
positive opinion recommending the granting of a marketing
authorization. Those efforts culminated in the European Commission
approving Sixmo in June 2019 for
substitution treatment for opioid dependence in clinically stable
adult patients who require no more than 8 mg/day of sublingual
buprenorphine, within a framework of medical, social and
psychological treatment.
- While Titan successfully established the infrastructure to
support Probuphine and began to stabilize revenues, it became clear
that it was also necessary to expand the sales outreach to grow the
business. Accordingly, in the second half of 2019 Titan completed
two financing transactions (August and October 2019) that provided total net proceeds of
approximately $9.9 million, after
which the Company began the process to expand the sales and
commercial team.
- Also, in the second half of 2019, the National Institutes of
Health's National Institute on Drug Abuse ("NIDA") approved
approximately $6.1 million in
second-year funding for Titan's non-clinical development of a
ProNeura™ based six-month implantable formulation of Nalmefene, an
opioid antagonist, intended for the prevention of relapse to opioid
addiction, following opioid detoxification.
Year-to-Date 2020 Business Highlights
- In January 2020, Titan completed
an offering resulting in net cash proceeds of approximately
$1.9 million.
- In January 2020, Titan signed an
agreement for Probuphine to be included on the Federal Supply
Schedule, providing U.S. veterans and other federal government
agencies with access to Titan's novel six-month maintenance
treatment for OUD in eligible patients.
- Since January 1, 2020, the
Company has received proceeds of approximately $6.2 million as a result of the exercise of
previously issued common stock purchase warrants.
"Throughout 2019, we focused on initiatives to successfully
transition to a commercial-stage company," said Titan's President
and CEO, Sunil Bhonsle. "I am very
pleased with our team's progress during 2019, which, among other
things, includes executing arrangements with multiple top tier
specialty pharmacy companies, establishing a new patient services
'hub,' and obtaining insurance coverage from a broad range of third
party payors – all of which served to broaden product access for
healthcare providers and patients. While we primarily focused on
stabilizing our product revenue during the transition, our goal
during the remainder of 2020 is to focus on executing our sales
growth initiatives in the U.S. and extending the commercial reach
of Probuphine to eligible patients suffering from OUD."
Probuphine is indicated for the maintenance treatment of OUD in
eligible patients. Please see Full Prescribing Information
including Boxed Warning below.
"An important 2019 milestone for Titan was the European
Commission's approval of Sixmo, Probuphine's brand name in the EU,"
said Titan's Executive Chairman, Dr. Marc
Rubin. "Our EU commercialization partner, Molteni, is
located in Italy, one of the
countries hit hardest by the global COVID-19 pandemic. While the
launch of Sixmo may be delayed as a result, we are confident that
Molteni is poised to aggressively roll-out the product across
Europe once the situation
allows."
Dr. Rubin continued, "As the developments involving the COVID-19
pandemic continue to evolve, we are monitoring and implementing
recommendations from local, national and global health
organizations. Titan's top priorities are the health and safety of
our employees, customers and the communities in which we live and
work. To that end, we have put proactive, precautionary measures in
place, such as sheltering in place and working from home, freezing
all non-essential travel, and we have pivoted to virtual sales and
business meetings only, with the goal of keeping everyone safe. At
the same time, we remain deeply committed to continuing to execute
additional components of our growth plan throughout 2020. These
include initiatives to increase awareness and adoption of
Probuphine, advance our Nalmefene program toward the clinic, and
explore opportunities for the use of our ProNeura platform
technology in additional important medical applications. Everyone
at Titan is working remotely and being productive. We sincerely
hope that all of our stakeholders will be safe and healthy as
well."
Fourth Quarter 2019 Financial Results
For the three months ended December 31,
2019, Titan reported approximately $1.2 million in revenue, which reflect
approximately $0.2 million in product
sales and approximately $1.0 million
related to the Company's NIDA grant. This compared with revenues of
approximately $1.2 million in the
same period in 2018, which was comprised of $0.2 million in product sales, $0.3 million related to the amortization of
deferred revenue related to the sale to Molteni of the European
intellectual property rights to Probuphine and $0.7 million related to the NIDA grant.
Total operating expenses for the fourth quarter of 2019 were
approximately $5.0 million,
compared with approximately $4.5
million from the same quarter in 2018, and consisted
primarily of research and development ("R&D") and selling,
general and administrative ("SG&A") expenses and costs of goods
sold, inclusive of distribution expenses. R&D expenses for both
the quarter ended December 31, 2019
and the same quarter in 2018 were approximately $1.9 million. SG&A expenses for the 2019
fourth quarter were approximately $2.6 million, compared with approximately
$2.4 million in the same quarter a
year ago. Costs of goods sold for the fourth quarter of 2019 were
approximately $0.6 million, compared
with approximately $0.3 million in
the 2018 fourth quarter.
Net other expense, consisting primarily of interest expense, was
approximately $0.1 million in
the fourth quarter of 2019, compared with net other expense of
approximately $0.2 million in the
fourth quarter of 2018.
Net loss applicable to common stockholders in the fourth quarter
of 2019 was approximately $4.0
million, or approximately $0.08 per share, compared with a net loss
applicable to common stockholders of approximately $3.5 million, or approximately $0.29 per share, in the same quarter in 2018.
Full Year 2019 Financial Results
Total revenues for the full year ended December 31, 2019 were approximately $3.6 million, reflecting approximately
$0.3 million in license revenue,
approximately $1.0 million from sales
of Probuphine and approximately $2.3
million related to Titan's NIDA grant. This compares to
total revenues of approximately $6.6
million in 2018 which included approximately $5.4 million in license revenue, approximately
$0.5 million from sales of Probuphine
and approximately $0.7 million
related to Titan's NIDA grant. The approximately $3.0 million decrease resulted primarily from
non-recurring license revenue in 2018 of approximately
$3.2 million in upfront and milestone
payments from Molteni, and approximately $2.1 million related to reacquiring the rights to
Probuphine from our former licensee which was partially offset by
increases in product revenue of approximately $0.5 million, and grant revenues of approximately
$1.6 million in 2019 and
approximately $0.3 million of license
revenue which represented the remaining amortization of the Molteni
upfront payment in 2019.
Total operating expenses in 2019 were approximately $20.5 million, compared with approximately
$14.9 million in 2018, and consisted
primarily of R&D and SG&A expenses. R&D expenses for
the year ended December 31, 2019 were
approximately $7.3 million compared
to approximately $7.5 million in
2018. The decrease in R&D costs was primarily associated
with decreases in employee-related expenses and other research and
development expenses, partially offset by increased activities
related to the NIDA grant and an increase in our contract
manufacturing costs. SG&A expenses for 2019 were approximately
$11.9 million, compared to
approximately $6.9 million in 2018.
The increase in SG&A expenses was primarily due to higher sales
and marketing expenses related to establishing the infrastructure
to streamline the Probuphine ordering and distribution network and
the increased expenses associated with expanding Titan's Probuphine
commercial activities.
Net other income for the year ended December 31, 2019 was approximately $0.4 million, compared to net other expense of
approximately $0.8 million in 2018.
Net other income in 2019 was primarily due to non-cash gain on
changes in the fair value of warrants. Net other expense in 2018
was primarily due to interest expense on the Company's debt.
Net loss applicable to common stockholders for 2019 was
approximately $16.5 million, or
$0.72 per share, compared with net
loss applicable to common stockholders of approximately
$9.3 million, or $1.64 per share, for 2018.
As at December 31, 2019, Titan had
cash and cash equivalents of approximately $5.2 million, which the Company believes,
together with the net cash proceeds of approximately $8.0 million received from the January 2020 offering and exercises of warrants
in the first quarter of 2020, are sufficient to fund planned
operations into the fourth quarter of 2020.
Conference Call Details
Titan management will host a conference call today at
4:30 p.m. ET / 1:30 p.m. PT to review these financial results
and discuss business developments in the period. The conference
call will be hosted by Sunil
Bhonsle, President and CEO; Kate
Beebe DeVarney, Ph.D., Executive Vice President and Chief
Scientific Officer; Dane Hallberg,
Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; and
Marc Rubin, M.D., Executive
Chairman.
The live conference call may be accessed by dialing
1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and
providing passcode 2248161. The call will also be broadcast live
and archived on Titan's website at www.titanpharm.com/news/events.
About Probuphine
Probuphine is the only subdermal implant designed to deliver
buprenorphine continuously for six months following insertion.
Probuphine was developed using ProNeura®, the continuous drug
delivery system developed by Titan that consists of a small, solid
implant made from a mixture of ethylene-vinyl acetate and a drug
substance. The resulting construct is a solid matrix that is placed
subdermally, normally in the upper inner arm in an outpatient
office procedure and removed in a similar manner at the end of the
treatment period. The U.S. Food and Drug Administration ("FDA")
approved Probuphine in May 2016, and
it is the first and only buprenorphine implant available for the
maintenance treatment of opioid addiction in eligible patients.
IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED
WARNING
INDICATION
PROBUPHINE is an implant that contains the medicine
buprenorphine. PROBUPHINE is used to treat certain adults who are
addicted to (dependent on) opioid drugs (either prescription or
illegal). PROBUPHINE is indicated for the maintenance treatment of
opioid dependence in patients who have achieved and sustained
prolonged clinical stability on low-to-moderate doses (doses no
more than 8 mg per day) of a buprenorphine-containing product.
PROBUPHINE is part of a complete treatment program that also
includes counseling and behavioral therapy.
It is not known if PROBUPHINE is safe or effective in children
less than 16 years of age.
IMPORTANT SAFETY INFORMATION
|
WARNING:
COMPLICATIONS FROM INSERTION AND REMOVAL OF
PROBUPHINE
|
See Full
Prescribing Information for complete Boxed Warning
|
|
|
Serious
complications may happen from insertion and removal of
PROBUPHINE, including:
|
|
•
|
Nerve or blood vessel
injury in your arm
|
|
•
|
Movement of implant
(migration). PROBUPHINE or pieces of it can move into blood
vessels, possibly to your lung, and could lead to death
|
|
•
|
Implant sticks out of
the skin (protrusion)
|
|
•
|
Implant comes out by
itself (expulsion)
|
|
|
Call your healthcare provider right away if:
- PROBUPHINE sticks out of the skin or comes out by itself
- You have bleeding or symptoms of infection at the site after
insertion or removal, including excessive or worsening itching,
pain, irritation, redness, or swelling
- You have numbness or weakness in your arm after the insertion
or removal procedure
- You have weakness or numbness in your arm, or shortness of
breath
If the implant comes out by itself, keep it away from others,
especially children, as it may cause severe difficulty in breathing
and possibly death.
Because of the risk of complications of, migration, protrusion,
expulsion and nerve injury with insertion and removal of
PROBUPHINE, it is only available through a restricted program
called the PROBUPHINE REMS Program. Healthcare providers who
prescribe and/or insert PROBUPHINE must be certified with the
program by enrolling and completing live training.
- PROBUPHINE is not available in retail pharmacies
- PROBUPHINE must be inserted or removed only in the facility of
the certified prescriber
Implants may be difficult to locate if inserted too deeply, if
you manipulate them, or if you gain significant weight after
insertion. Your healthcare provider may do special procedures
or tests, or refer you to a surgical specialist to remove the
implants if they are difficult to locate.
The medicine in PROBUPHINE can cause serious and
life-threatening problems, especially if you take or use certain
other medicines or drugs. Call your healthcare provider right
away or get emergency help if you:
Feel faint or dizzy, have mental changes such as confusion,
slower breathing than you normally have, severe sleepiness, blurred
vision, problems with coordination, slurred speech, cannot think
well or clearly, high body temperature, slowed reflexes, feel
agitated, stiff muscles or have trouble walking.
These can be signs of an overdose or other serious
problems.
Coma or death can happen if you take anxiety medicines or
benzodiazepines, sleeping pills, tranquilizers, or sedatives,
antidepressants, or antihistamines, or drink alcohol during
treatment with PROBUPHINE. Tell your healthcare provider if you are
taking any of these medicines or if you drink alcohol.
Who should not use PROBUPHINE?
Do not use PROBUPHINE if you are allergic to buprenorphine or
any of its ingredients, this includes buprenorphine hydrochloride
and the inactive ingredient ethylene vinyl acetate or EVA.
PROBUPHINE may not be right for you. Before starting
PROBUPHINE tell your doctor about all of your medical conditions,
including:
Trouble breathing or lung problems, an enlarged prostate gland
(men), a head injury or brain problem, problems urinating, a curve
in your spine that affects your breathing, liver problems,
gallbladder or adrenal gland problems, Addison's disease, low
thyroid hormone levels (hypothyroidism), a history of alcoholism, a
history of keloid formation, connective tissue disease (such as
scleroderma), or history of MRSA infections, mental problems such
as hallucinations, an allergy to numbing medicines or medicines
used to clean your skin, are pregnant or plan to become pregnant or
are breastfeeding or plan to breastfeed.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements.
What should I avoid while being treated with
PROBUPHINE?
- Do not drive, operate heavy machinery, or perform any other
dangerous activities until you know how this medication affects
you
- You should not drink alcohol during treatment. You
should not take anxiety medicines or benzodiazepines, sleeping
pills, tranquilizers, or sedatives that are not prescribed to you
during treatment with PROBUPHINE, as this can lead to slowed
breathing, drowsiness, delayed reaction time, loss of consciousness
or even death
What are the possible side effects of PROBUPHINE?
PROBUPHINE can cause serious side effects, including:
- Infection at the insertion or removal
site. Infection may happen at the implant site during
insertion or removal. Do not try to remove PROBUPHINE implants
yourself
- Opioid withdrawal. If PROBUPHINE comes out of your
arm or if you stop treatment, tell your doctor right away as you
can have symptoms of shaking, sweating more than normal, feeling
hot or cold more than normal, runny nose, watery eyes, goose bumps,
diarrhea, vomiting and muscle aches
- Physical dependency
- Liver problems. Call your doctor right away if you
notice signs of liver problems that may include your skin or the
white part of your eyes turning yellow (jaundice)
- Allergic reaction. If you get a rash, hives,
itching, swelling of your face, or wheezing, low blood pressure,
dizziness or decrease in consciousness
- Decrease in blood pressure. You may feel dizzy when you
get up from sitting or lying down
- Sleep Apnea. Call your doctor right away if you or
someone close to you notices: Observed episodes of stopped
breathing or abnormal breathing patterns during sleep
Tell your healthcare provider if you develop any of the
symptoms listed.
Common side effects of PROBUPHINE include: Headache,
nausea, toothache, constipation, depression, vomiting, back pain,
mouth and throat pain.
Common risks with the minor surgical procedure:
Itching, pain, irritation, redness, swelling, bleeding, or bruising
at the insertion or removal site. Scarring around the insertion
site.
Please read Full Prescribing Information,
including BOXED WARNING regarding IMPLANT MIGRATION,
PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION
AND REMOVAL.
Titan encourages you to report negative side effects of
prescription drugs to the FDA. You can
visit www.fda.gov/safety/medwatch/ or call
1-800-FDA-1088.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage
company developing proprietary therapeutics with its
ProNeura® long-term, continuous drug delivery technology.
The Company's lead product is Probuphine® (buprenorphine) implant,
a novel and long-acting formulation of buprenorphine for the
long-term maintenance treatment of opioid dependence. Approved by
the U.S. Food and Drug Administration in May
2016, Probuphine is the first and only commercialized
treatment of opioid dependence to provide continuous,
around-the-clock blood levels of buprenorphine for six months
following a single procedure. The ProNeura technology also has the
potential to be used in developing products for treating other
chronic conditions such as Parkinson's disease and hypothyroidism,
where maintaining consistent, around-the-clock blood levels of
medication may benefit the patient and improve medical outcomes.
For more information about Titan, please visit
www.titanpharm.com.
Forward-Looking Statements
This press release may contain "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Such statements
include, but are not limited to, any statements relating to our
product development programs and any other statements that are not
historical facts. Such statements involve risks and uncertainties
that could negatively affect our business, operating results,
financial condition and stock price. Factors that could cause
actual results to differ materially from management's current
expectations include those risks and uncertainties relating to the
commercialization of Probuphine; the regulatory approval process;
Titan's ability to access capital; the development, testing,
production and marketing of our drug candidates; patent and
intellectual property matters; and strategic agreements and
relationships. We expressly disclaim any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in our expectations or any changes in events, conditions or
circumstances on which any such statement is based, except as
required by law.
CONTACTS:
Sunil Bhonsle
President & CEO
(650) 244-4990
Stephen Kilmer
Investor Relations
(650) 989-2215
TITAN
PHARMACEUTICALS, INC.
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(in thousands,
except per share amount*)
|
(unaudited)
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenue:
|
|
|
|
|
|
|
|
|
License
revenue
|
$
2
|
|
$
313
|
|
$
315
|
|
$
5,376
|
|
Product
revenue
|
195
|
|
217
|
|
1,006
|
|
535
|
|
Grant
revenue
|
1,020
|
|
707
|
|
2,290
|
|
707
|
|
|
Total
revenue
|
1,217
|
|
1,237
|
|
3,611
|
|
6,618
|
|
|
|
|
|
|
|
|
|
|
Operating
expense:
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
550
|
|
290
|
|
1,288
|
|
538
|
|
Research and
development
|
1,872
|
|
1,855
|
|
7,242
|
|
7,478
|
|
Selling, general and
administrative
|
2,589
|
|
2,358
|
|
11,925
|
|
6,866
|
|
|
Total operating
expense
|
5,011
|
|
4,503
|
|
20,455
|
|
14,882
|
Loss from
operations
|
(3,794)
|
|
(3,266)
|
|
(16,844)
|
|
(8,264)
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
(147)
|
|
(238)
|
|
386
|
|
(759)
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
$
(3,941)
|
|
$
(3,504)
|
|
$
(16,458)
|
|
$
(9,023)
|
Deemed dividend on
trigger of down round provision
|
-
|
|
-
|
|
-
|
|
(285)
|
Net loss attributable
to common stockholders
|
$
(3,941)
|
|
$
(3,504)
|
|
$
(16,458)
|
|
$
(9,308)
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per
share
|
$
(0.08)
|
|
$
(0.29)
|
|
$
(0.72)
|
|
$
(1.64)
|
|
|
|
|
|
|
|
|
|
|
Diluted net loss per
share
|
$
(0.08)
|
|
$
(0.29)
|
|
$
(0.72)
|
|
$
(1.66)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used in computing basic net loss per share
|
49,206
|
|
11,960
|
|
22,957
|
|
5,688
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used in computing diluted net loss per share
|
49,206
|
|
11,960
|
|
22,957
|
|
5,688
|
|
* Adjusted to reflect
the impact of the 1:6 reverse split effective January 24,
2019.
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
5,223
|
|
$
9,295
|
|
Restricted
cash
|
|
|
-
|
|
361
|
|
Receivables
|
|
|
993
|
|
1,737
|
|
Inventory
|
|
|
998
|
|
1,262
|
|
Contract
assets
|
|
|
-
|
|
99
|
|
Prepaid expenses and
other current assets
|
|
|
1,094
|
|
547
|
|
|
Total current
assets
|
|
|
8,308
|
|
13,301
|
|
Property and
equipment, net
|
|
|
817
|
|
794
|
|
Operating lease
right-of-use asset
|
|
|
397
|
|
-
|
|
|
Total
assets
|
|
|
$
9,522
|
|
$
14,095
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
Current
liabilities
|
|
|
$
3,600
|
|
$
3,452
|
|
Long-term
debt
|
|
|
4,019
|
|
3,787
|
|
Warrant
liability
|
|
|
320
|
|
-
|
|
Derivative
liability
|
|
|
-
|
|
25
|
|
Operating lease
liability, non-current
|
|
|
150
|
|
-
|
|
Stockholders'
equity
|
|
|
1,433
|
|
6,831
|
|
|
Total liabilities and
stockholders' equity
|
|
|
$
9,522
|
|
$
14,095
|
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SOURCE Titan Pharmaceuticals, Inc.