SOUTH SAN FRANCISCO, Calif.,
May 15, 2019 /PRNewswire/
-- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today reported
financial results for the first quarter ended March 31, 2019 and provided an update on its
business.
First Quarter 2019 and Recent Business Highlights
- In January 2019, Titan provided
an update on its commercial activities, including positive initial
results of the U.S. relaunch of Probuphine®
(buprenorphine) implant, Titan's unique six-month maintenance
treatment for opioid use disorder (OUD) in eligible
patients.
- In February 2019, Titan executed
a specialty pharmacy distribution and services agreement for
Probuphine with AllianceRx Walgreens Prime. In March 2019, Walgreens placed a material bulk
order to stock its specialty pharmacies in five key geographies to
meet anticipated product demand, revenues from which will continue
to be recognized over future quarters, in accordance with U.S.
GAAP.
- In March 2019, Titan announced an
agreement with AppianRx establishing a new 'hub' that provides a
full suite of patient and healthcare provider support services
related to Probuphine.
- In April 2019, Titan and Molteni
& C. dei F.lli Alitti Società di Esercizio S.p.A. ("Molteni")
announced that the Committee for Medicinal Products for Human Use
("CHMP") of the European Medicines Agency adopted a positive
opinion recommending the granting of a marketing authorization for
Sixmo, the brand name for Probuphine implant in the European Union.
The European Commission is expected to issue its decision toward
the end of June 2019.
- In May 2019, Titan announced a
product purchase and supply agreement for Probuphine with
Accredo® specialty pharmacy, a subsidiary of Express
Scripts.
"We have made important progress on our
Probuphine commercialization strategy since
the beginning of 2019," said Titan's President and CEO,
Sunil Bhonsle.
"We significantly expanded our specialty pharmacy
network by bringing on board two nationally-recognized specialty
pharmacies Alliance Rx Walgreens Prime and Accredo, and
established AppianRx as the 'hub' that will streamline Probuphine's
supply chain process. These new partnerships will improve
access to long-term maintenance treatment with Probuphine for
eligible patients and facilitate more efficient interactions among
specialty pharmacies, physicians and payors. We have also made good
progress in early-stage product development funded through grants
from the National Institutes of Health and others, and continue to
explore opportunities to expand the use of our
ProNeuraTM technology through more
partnerships."
Titan's Executive Chairman, Dr. Marc
Rubin, commented, "In addition to expanding our specialty
pharmacy network and enhancing patient support services, we have
continued to increase awareness of Probuphine by exhibiting at the
American Society of Addiction Medicine annual meeting in April, and
have expanded our base of healthcare providers who can provide
treatment with Probuphine. We are pleased with the CHMP's adoption
of a positive opinion regarding Sixmo in Europe. We look forward to the European
Commission's final decision, and to supporting our partner,
Motleni, as it prepares to launch Sixmo in the world's second
largest market for buprenorphine-based products."
First Quarter 2019 Financial Results
For the three months ended March 31,
2019, Titan reported approximately $0.9 million in revenues, which reflect
approximately $0.3 million in product
revenues, representing a growth of approximately 46% sequentially
over the prior quarter, $0.3 million
of grant revenues and $0.3 million of
amortization of deferred revenue from the sale of European
intellectual property rights for Probuphine to Molteni. This
compared with revenues of approximately $1.1
million in the same period in 2018, which were primarily
related to the up-front payment from the sale of Titan's European
intellectual property rights for Probuphine to Molteni.
Total operating expenses for the first quarter of 2019 were
approximately $5.2 million, compared
with approximately $3.5 million in
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 the quarter ended
March 31, 2019 were approximately
$1.8 million, compared with
approximately $1.9 million for the
same quarter in 2018. SG&A expenses for the 2019 first quarter
were approximately $3.1 million and
included approximately $1.7 million
associated with sales and marketing and approximately $1.4 of general administrative expenses, compared
with approximately $1.6 million in
the same quarter a year ago which were essentially general and
administrative expenses. Costs of goods sold, which reflects
product costs and other distribution expenses associated with sales
of Probuphine, were approximately $0.3
million for the first quarter of 2019. Titan did not have
cost of goods sold for the three months ended March 31, 2018.
Net other expense was approximately $0.2
million for the three month periods ended March 31, 2019 and 2018, primarily attributable
to interest expense on outstanding loans.
Net loss applicable to common shareholders in the first quarter
of 2019 was approximately $4.5
million, or approximately $0.34 per share, compared with a net loss
applicable to common shareholders of approximately $2.6 million, or approximately $0.74 per share, in the same quarter in 2018.
As of March 31, 2019, Titan had
cash and cash equivalents of approximately $5.9 million.
Conference Call Details
Titan management will host a conference call today at
4:30 p.m. EDT today 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 1059834. 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 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 transmucosal buprenorphine-containing
product.
PROBUPHINE is part of a complete treatment program that also
includes counseling and behavioral therapy.
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WARNING :
COMPLICATIONS FROM INSERTION AND REMOVAL OF
PROBUPHINE
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See Full
Prescribing Information for complete Boxed Warning
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Serious
complications may happen from insertion and removal of
PROBUPHINE, including:
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•
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Nerve or blood vessel
injury in your arm
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•
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Movement of implant
(migration). PROBUPHINE or pieces of it can move into blood vessels
and to your lung, and could lead to death.
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•
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Implant sticks out of
the skin (protrusion)
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•
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Implant comes out by
itself (expulsion)
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Contraindications
Hypersensitivity to buprenorphine or any other ingredients in
PROBUPHINE (e.g., EVA).
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
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
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.
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.
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,
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
skilmer@titanpharm.com
TITAN
PHARMACEUTICALS, INC.
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CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(in thousands,
except per share amount)
|
(unaudited)
|
|
|
|
|
|
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Three Months
Ended
March 31,
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|
|
|
|
|
|
2019
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|
2018
|
|
Revenue:
|
|
|
|
|
|
|
|
License
revenue
|
|
|
$
313
|
|
$
1,064
|
|
|
Product
revenue
|
|
|
317
|
|
-
|
|
|
Grant
revenue
|
|
|
315
|
|
-
|
|
|
|
Total
revenue
|
|
|
945
|
|
1,064
|
|
|
|
|
|
|
|
|
|
|
Operating
expense:
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
304
|
|
-
|
|
|
Research and
development
|
|
|
1,844
|
|
1,856
|
|
|
Selling, general and
administrative
|
|
|
3,082
|
|
1,615
|
|
|
|
Total operating
expense
|
|
|
5,230
|
|
3,471
|
|
Loss from
operations
|
|
|
(4,285)
|
|
(2,407)
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
|
(232)
|
|
(198)
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|
|
|
|
|
|
|
|
|
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Net loss and
comprehensive loss
|
|
|
$
(4,517)
|
|
$
(2,605)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
|
$
(0.34)
|
|
$
(0.74)
|
|
|
|
|
|
|
|
|
|
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Weighted average
shares used in computing
|
|
|
|
|
|
|
|
basic and diluted net
loss per common share
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13,217
|
|
3,534
|
|
|
|
|
|
|
|
|
|
|
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CONDENSED BALANCE
SHEETS
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(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
|
|
|
|
2019
|
|
2018
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|
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|
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|
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Assets
|
|
|
|
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Cash and cash
equivalents
|
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$
5,909
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|
$
9,295
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Restricted
cash
|
|
|
-
|
|
361
|
|
|
Receivables
|
|
|
2,052
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|
1,737
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|
|
Inventory
|
|
|
1,246
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|
1,262
|
|
|
Contract
assets
|
|
|
-
|
|
99
|
|
|
Prepaid expenses and
other current assets
|
|
|
882
|
|
547
|
|
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Total current
assets
|
|
|
10,089
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|
13,301
|
|
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Furniture and
equipment, net
|
|
|
782
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|
794
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|
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Operating lease
right-of-use asset
|
|
|
569
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-
|
|
|
|
Total
assets
|
|
|
$
11,440
|
|
$
14,095
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Liabilities and
Stockholders' Equity
|
|
|
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|
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Current
liabilities
|
|
|
$
4,761
|
|
$
3,452
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|
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Operating lease
liability, non-current
|
|
|
357
|
|
-
|
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|
Long-term
debt
|
|
|
3,242
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|
3,787
|
|
|
Derivative
liability
|
|
|
25
|
|
25
|
|
|
Stockholders'
equity
|
|
|
3,055
|
|
6,831
|
|
|
|
Total liabilities and
stockholders' equity
|
$
11,440
|
|
$
14,095
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SOURCE Titan Pharmaceuticals, Inc.