Blueprint
EXHIBIT
99.1
2017 Third
Quarter
Management
Discussion and Analysis
MANAGEMENT
DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
FOR THE THREE AND NINE MONTHS ENDED AUGUST 31, 2017
The
following Management Discussion and Analysis
(“MD&A”) should be read in conjunction with the
August 31, 2017 condensed unaudited interim consolidated financial
statements of Intellipharmaceutics International Inc. The condensed
unaudited interim consolidated financial statements have been
prepared in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”),
as outlined in the Financial Accounting Standards Board
(“FASB”) Accounting Standards Codification
(“ASC”). Our accounting policies have the potential to
have a significant impact on our condensed unaudited interim
consolidated financial statements, either due to the significance
of the financial statement item to which they relate or because
they require judgment and/or estimation due to the uncertainty
involved in measuring, at a specific point in time, events which
are continuous in nature. The information contained in this
document is current in all material respects as of October
10, 2017 unless
otherwise noted.
Unless
the context otherwise requires, the terms “we”,
“us”, “our”,
“Intellipharmaceutics”, and the “Company”
refer to Intellipharmaceutics International Inc. and its
subsidiaries. Any reference in this document to our
“products” includes a reference to our product
candidates and future products we may develop. Whenever we refer to
any of our current product candidates (including additional product
strengths of products we are currently marketing), no assurances
can be given that we, or any of our strategic partners, will
successfully commercialize or complete the development of any of
such product candidates or future products under development or
proposed for development, that regulatory approvals will be granted
for any such product candidate or future product, or that any
approved product will be produced in commercial quantities or sold
profitably.
Unless
stated otherwise, all references to “$” are to the
lawful currency of the United States and all references to
“C$” are to the lawful currency of Canada. We refer in
this document to information regarding potential markets for our
products, product candidates and other industry data. We believe
that all such information has been obtained from reliable sources
that are customarily relied upon by companies in our industry.
However, we have not independently verified any such
information.
Intellipharmaceutics™,
Hypermatrix™, Drug Delivery Engine™,
IntelliFoam™, IntelliGITransporter™,
IntelliMatrix™, IntelliOsmotics™, IntelliPaste™,
IntelliPellets™, IntelliShuttle™, RexistaTM, nPODDDS™,
PODRAS™ and Regabatin™ are our trademarks. These
trademarks are important to our business. Although we may have
omitted the “TM” trademark designation for such
trademarks in this document, all rights to such trademarks are
nevertheless reserved. Unless otherwise noted, other trademarks
used in this document are the property of their respective
holders.
FORWARD-LOOKING STATEMENTS
Certain
statements in this document constitute “forward-looking
statements” within the meaning of the United States Private
Securities Litigation Reform Act of 1995 and/or
“forward-looking information” under the Securities Act
(Ontario). These statements include, without limitation, statements
expressed or implied regarding our plans, goals and milestones,
status of developments or expenditures relating to our business,
plans to fund our current activities, statements concerning our
partnering activities, health regulatory submissions, strategy,
future operations, future financial position, future sales,
revenues and profitability, projected costs and market penetration.
In some cases, you can identify forward-looking statements by
terminology such as “may”, “will”,
“should”, “expects”, “plans”,
“plans to”, “anticipates”,
“believes”, “estimates”,
“predicts”, “confident”,
“prospects”, “potential”,
“continue”, “intends”, "look forward",
“could”, or the negative of such terms or other
comparable terminology. We made a number of assumptions in the
preparation of our forward-looking statements. You should not place
undue reliance on our forward-looking statements, which are subject
to a multitude of known and unknown risks and uncertainties that
could cause actual results, future circumstances or events to
differ materially from those stated in or implied by the
forward-looking statements.
Risks,
uncertainties and other factors that could affect our actual
results include, but are not limited to, the
effects of general economic conditions, securing and maintaining
corporate alliances, our estimates regarding our capital
requirements and the effect of capital market conditions and other
factors, including the current status of our product development
programs, on capital availability, the estimated proceeds (and the
expected use of any proceeds) we may receive from any offering of
our securities, the potential dilutive effects of any future
financing, potential
liability from and costs of defending pending or future litigation,
our ability to maintain compliance with the continued listing
requirements of the principal markets on which our securities are
traded, our programs regarding research, development and
commercialization of our product candidates, the timing of such
programs, the timing, costs and uncertainties regarding obtaining
regulatory approvals to market our product candidates and the
difficulty in predicting the timing and results of any product
launches, the timing and amount of profit-share payments from our
commercial partners, and the timing and amount of any available
investment tax credits. Other factors that could cause actual
results to differ materially include but are not limited
to:
●
the actual or
perceived benefits to users of our drug delivery technologies,
products and product candidates as compared to others;
●
our ability to
establish and maintain valid and enforceable intellectual property
rights in our drug delivery technologies, products and product
candidates;
●
the scope of
protection provided by intellectual property for our drug delivery
technologies, products and product candidates;
●
the actual size of
the potential markets for any of our products and product
candidates compared to our market estimates;
●
our selection and
licensing of products and product candidates;
●
our ability to
attract distributors and/or commercial partners with the ability to
fund patent litigation and with acceptable product development,
regulatory and commercialization expertise and the benefits to be
derived from such collaborative efforts;
●
sources of revenues
and anticipated revenues, including contributions from distributors
and commercial partners, product sales, license agreements and
other collaborative efforts for the development and
commercialization of product candidates;
●
our ability to
create an effective direct sales and marketing infrastructure for
products we elect to market and sell directly;
●
the rate and degree
of market acceptance of our products;
●
delays in product
approvals that may be caused by changing regulatory
requirements;
●
the difficulty in
predicting the timing of regulatory approval and launch of
competitive products;
●
the difficulty in
predicting the impact of competitive products on volume, pricing,
rebates and other allowances;
●
the number of
competitive product entries, and the nature and extent of any
aggressive pricing and rebate activities that may
follow;
●
the inability to
forecast wholesaler demand and/or wholesaler buying
patterns;
●
the seasonal
fluctuation in the numbers of prescriptions written for our Focalin
XR® (dexmethylphenidate hydrochloride extended-release)
capsules, which may produce substantial fluctuations in
revenues;
●
the timing and
amount of insurance reimbursement regarding our
products;
●
changes in laws and
regulations affecting the conditions required by the United States
Food and Drug Administration (“FDA”) for approval,
testing and labeling of drugs including abuse or overdose deterrent
properties, and changes affecting how opioids are regulated and
prescribed by physicians;
●
changes in laws and
regulations, including Medicare and Medicaid, affecting among other
things, pricing and reimbursement of pharmaceutical
products;
●
changes in U.S.
federal income tax laws currently being considered, including, but
not limited to, the U.S. changing the method by which foreign
income is taxed and resulting changes to the passive foreign
investment company laws and regulations which may impact our
shareholders;
●
the success and
pricing of other competing therapies that may become
available;
●
our ability to
retain and hire qualified employees;
●
the availability
and pricing of third-party sourced products and
materials;
●
challenges related
to the development, commercialization, technology transfer,
scale-up, and/or process validation of manufacturing processes for
our products or product candidates;
●
the manufacturing
capacity of third-party manufacturers that we may use for our
products;
●
potential product
liability risks;
●
the recoverability
of the cost of any pre-launch inventory should a planned product
launch encounter a denial or delay of
approval by regulatory bodies, a delay in commercialization, or
other potential issues;
●
the successful
compliance with FDA, Health Canada and other governmental
regulations applicable to us and our third party
manufacturers’ facilities, products and/or
businesses;
●
our reliance on
commercial partners, and any future commercial partners, to market
and commercialize our products and, if approved, our product
candidates;
●
difficulties,
delays, or changes in the FDA approval process or test criteria for
Abbreviated New Drug Applications (“ANDAs”) and New
Drug Applications (“NDAs”);
●
challenges in
securing final FDA approval for our product candidates, including
oxycodone hydrochloride extended release tablets (previously
referred to as RexistaTM)(“Oxycodone
ER”) in particular, if a patent infringement suit is filed
against us, with respect to any particular product candidates (such
as in the case of Oxycodone ER), which could delay the FDA’s
final approval of such product candidates;
●
healthcare reform
measures that could hinder or prevent the commercial success of our
products and product candidates;
●
the FDA may not
approve requested product labeling for our product candidate(s)
having abuse-deterrent properties targeting common forms of abuse
(oral, intra-nasal and intravenous);
●
risks or
uncertainties related to the Company’s ability to implement
and execute its plan to regain compliance with NASDAQ continued
listing standards;
●
risks associated
with cyber-security and the potential for vulnerability of our
digital information or the digital information of a current and/or
future drug development or commercialization partner of
ours; and
●
risks arising from
the ability and willingness of our third-party commercialization
partners to provide documentation that may be required to support
information on revenues earned by us from those commercialization
partners.
Additional
risks and uncertainties relating to us and our business can be
found in our reports, public disclosure documents and other filings
with the securities commissions and other regulatory bodies in
Canada and the U.S. which are available on www.sedar.com and www.sec.gov. The forward-looking
statements reflect our current views with respect to future events,
and are based on what we believe are reasonable assumptions as of
the date of this document. We disclaim any intention and have no
obligation or responsibility, except as required by law, to update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
This
discussion should not be construed to imply that the results
discussed herein will necessarily continue into the future, or that
any conclusion reached herein will necessarily be indicative of our
actual operating results.
CORPORATE DEVELOPMENTS
●
In
September 2017 the Company received a Complete Response Letter
("CRL") for its Oxycodone ER NDA, indicating that the FDA could not
approve the application in its present form. In its CRL, the FDA
provided certain recommendations and requests for information,
including that Intellipharmaceutics complete the relevant Category
2 and Category 3 studies to assess the abuse-deterrent properties
of Oxycodone ER by the oral and nasal routes of administration. The
FDA also requested additional information related to the inclusion
of the blue dye in the Oxycodone ER formulation, which is intended
to deter abuse, and that Intellipharmaceutics submit an alternate
proposed proprietary name for Oxycodone ER. Intellipharmaceutics
has been given one year to respond to the CRL, and can request
additional time if necessary.
●
In
September 2017, the Company announced that it has received written
notification (the "Notification Letter") from The NASDAQ Stock
Market LLC ("Nasdaq") notifying the Company that it is not in
compliance with the minimum market value of listed securities
requirement set forth in Nasdaq Rules for continued listing on The
Nasdaq Capital Market. The Notification Letter does not impact the
Company's listing on The Nasdaq Capital Market at this time. Nasdaq
Listing Rule 5550(b)(2) requires listed securities to maintain a
minimum market value of US $35.0 million, and Listing Rule
5810(c)(3)(C) provides that a failure to meet the minimum market
value requirement exists if the deficiency continues for a period
of 30 consecutive business days. Based on the market value of the
Company's common shares for the 30 consecutive business days
from August 8, 2017, the Company no longer meets the minimum
market value of listed securities requirement. In accordance with
Nasdaq Listing Rule 5810(c)(3)(C), the Company has been provided
180 calendar days, or until March 19, 2018, to regain compliance
with Nasdaq Listing Rule 5550(b)(2). To regain compliance, the
Company's common shares must have a market value of at least US
$35.0 million for a minimum of 10 consecutive business days. In the
event the Company does not regain compliance by March 19, 2018, the
Company may be eligible for additional time to regain
compliance.
●
In July 2017, the
Company announced a purported class action complaint was filed in
the U.S. District Court for the Southern District of New York (the
“S.D.N.Y Court”) (No. 1:17-cv-05761) by Shawn Shanawaz
on behalf of himself and all others similarly situated against the
Company and two of its executive officers. The complaint alleges
that the Company and the executive officers violated Sections 10(b)
and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5
promulgated thereunder by making allegedly false and misleading
statements or failing to disclose certain information regarding the
Company’s NDA for Oxycodone ER abuse-deterrent oxycodone
hydrochloride extended release tablets. The complaint seeks, among
other remedies, unspecified damages, attorneys’ fees and
other costs, equitable and/or injunctive relief, and such other
relief as the court may find just and proper. Subsequently in
August 2017, two additional substantially similar (in substance and
relief sought) actions were filed by Guy Braverman (No.
1:17-cv-06045) and David Ducharme (No. 1:17-cv-06621) in the
S.D.N.Y. Court. We anticipate that all three actions will be
consolidated into one complaint. The Company and its management
intend to vigorously defend against the allegations set forth in
the complaints.
●
In July 2017, the Company announced that the
Anesthetic and Analgesic Drug Products Advisory Committee and Drug
Safety and Risk Management Advisory Committee of the FDA (the
“FDA Advisory Committee”) voted 22 to 1 in finding that
the Company’s NDA for Oxycodone ER abuse-deterrent oxycodone
hydrochloride extended release tablets should not be approved at
this time. The committees also voted 19 to 4 that the
Company has not demonstrated that Oxycodone ER has properties that can be expected
to deter abuse by the intravenous route of administration, and 23
to 0 that there are not sufficient data for Oxycodone ER to support inclusion of
language regarding abuse-deterrent properties in the product label
for the intravenous route of
administration. The committees
expressed a desire to review the additional safety and efficacy
data for Oxycodone ER that may be obtained from human abuse
potential studies for the oral and intranasal routes of
administration.
●
In June 2017, we
announced that Mallinckrodt LLC (“Mallinckrodt”), in
its capacity as the Company’s marketing and distribution
partner, launched all strengths of the Company’s generic
Seroquel XR® (quetiapine fumarate extended-release tablets) in
the U.S. This launch follows the recent final approval
from the FDA for the Company's ANDA for quetiapine fumarate
extended-release tablets in the 50, 150, 200, 300 and 400 mg
strengths. The approved product is a generic equivalent of the
corresponding strengths of the branded product Seroquel XR®
sold in the U.S. by Astra Zeneca Pharmaceuticals LP
(“AstraZeneca”). Under its license and commercial
supply agreement with Mallinckrodt, the Company manufactures and
supplies generic Seroquel XR® for Mallinckrodt to market, sell
and distribute in the U.S.
There
can be no assurance that our generic Seroquel XR® product will
be successfully commercialized or produce significant revenues for
us. Also, there can be no assurance that we will not be required to
conduct further studies for our Oxycodone ER product, that the FDA
will approve any of the Company’s requested abuse-deterrence
label claims or that the FDA will ultimately approve the NDA for
the sale of our Oxycodone ER product in the U.S. market, or that it
will ever be successfully commercialized, that we will be
successful in submitting any additional ANDAs or NDAs with the FDA
or Abbreviated New Drug Submissions (“ANDSs”) with
Health Canada, that the FDA or Health Canada will approve any of
our current or future product candidates for sale in the U.S.
market and Canadian market, or that they will ever be successfully
commercialized and produce significant revenue for us. Also, there
can be no assurance that the Company can achieve Nasdaq’s
minimum market value of listed securities or other
requirements.
BUSINESS OVERVIEW
On
October 22, 2009, Intellipharmaceutics Ltd. (“IPC
Ltd.”) and Vasogen Inc. (“Vasogen”) completed a
court-approved plan of arrangement and merger (the “IPC
Arrangement Agreement”), resulting in the formation of the
Company, which is incorporated under the laws of Canada and the
common shares of which are traded on the Toronto Stock Exchange and
NASDAQ.
We are a pharmaceutical company
specializing in the research, development and manufacture of novel
and generic controlled-release and targeted-release oral solid
dosage drugs. Our patented Hypermatrix™ technology is a
multidimensional controlled-release drug delivery platform that can
be applied to the efficient development of a wide range of existing
and new pharmaceuticals. Based on this technology platform, we have
developed several drug delivery systems and a pipeline of products
(some of which have received FDA approval) and product candidates
in various stages of development, including ANDAs filed with the
FDA (and one ANDS filed with Health Canada) and one NDA filing, in
therapeutic areas that include neurology, cardiovascular,
gastrointestinal tract (“GIT”), diabetes and
pain.
In
November 2005, we entered into the license and commercialization
agreement between Par Pharmaceutical Inc. (“Par”) and
us (as amended, the “Par agreement”), pursuant to which
we granted Par an exclusive, royalty-free license to make and
distribute in the U.S. all strengths of our generic Focalin
XR® (dexmethylphenidate hydrochloride extended-release)
capsules for a period of 10 years from the date of commercial
launch (which was November 19, 2013). Under the Par agreement, we
made a filing with the FDA for approval to market generic Focalin
XR® capsules in various strengths in the U.S. (the
“Company ANDA”), and are the owner of that Company
ANDA, as approved in part by the FDA. We retain the right to make
and distribute all strengths of the generic product outside of the
U.S. Calendar quarterly profit-sharing payments for its U.S. sales
under the Company ANDA are payable by Par to us as calculated
pursuant to the Par agreement. Within the purview of the Par
agreement, Par also applied for and owns an ANDA pertaining to all
marketed strengths of generic Focalin XR® (the “Par
ANDA”), and is now approved by the FDA, to market generic
Focalin XR® capsules in all marketed strengths in the U.S. As
with the Company ANDA, calendar quarterly profit-sharing payments
are payable by Par to us for its U.S. sales of generic Focalin
XR® under the Par ANDA as calculated pursuant to the Par
agreement.
We
received final approval from the FDA in November 2013 under the
Company ANDA to launch the 15 and 30 mg strengths of our generic
Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules.
Commercial sales of these strengths were launched immediately by
our commercialization partner in the U.S., Par. In January 2017,
Par launched the 25 and 35 mg strengths of its generic Focalin
XR®
capsules in the U.S., and in May 2017, Par launched the 10 and 20
mg strengths, complementing the 15 and 30 mg strengths of our
generic Focalin XR® marketed by
Par. The FDA recently granted final approval under the Par ANDA for
its generic Focalin XR® capsules in the
5, 10, 15, 20, 25, 30, 35 and 40 mg strengths, and we believe Par
is preparing to launch the remaining 5 and 40 mg strengths in the
near future. Under the Par agreement, we receive quarterly profit
share payments on Par’s U.S. sales of generic Focalin
XR®.
We expect revenues from sales of the generic Focalin XR® capsules to
continue to grow for the next several quarters as the newly
approved strengths begin to gain market share. There can be no
assurance as to when or if any further launches will occur for the
remaining strengths, or if they will be successfully
commercialized.
In
February 2017, we received final approval from the FDA for our ANDA
for metformin hydrochloride extended release tablets in the 500 and
750 mg strengths. Our newly-approved product is a generic
equivalent for the corresponding strengths of the branded product
Glucophage® XR sold in the
U.S. by Bristol-Myers Squibb. The Company is aware that several
other generic versions of this product are currently available and
serve to limit the overall market opportunity, however, we are
continuing to evaluate options to realize commercial returns from
this new approval through a potential partnership arrangement.
There can be no assurance that our metformin hydrochloride extended
release tablets for the 500 and 750 mg strengths will be
successfully commercialized.
In
February 2016, we received final approval from the FDA of our ANDA
for generic Keppra XR® (levetiracetam
extended-release tablets) for the 500 and 750 mg strengths. Our
generic Keppra XR® is a generic
equivalent for the corresponding strengths of the branded product
Keppra XR® sold in the
U.S. by UCB, Inc., and is indicated for use in the treatment of
partial onset seizures associated with epilepsy. We are aware that
several other generic versions of this product are currently
available and serve to limit the overall market opportunity. We are
actively exploring the best approach to maximize our commercial
returns from this approval. There can be no assurance that our
generic Keppra XR® for the 500 and
750 mg strengths will be successfully commercialized.
In
October 2016, we received tentative approval from the FDA for our
ANDA for quetiapine fumarate extended-release tablets in the 50,
150, 200, 300 and 400 mg strengths, and in May 2017, our ANDA
received final FDA approval for all of these strengths. Our
approved product is a generic equivalent for the corresponding
strengths of the branded product Seroquel XR® sold in the U.S.
by AstraZeneca. Pursuant to a settlement agreement between us and
AstraZeneca dated July 30, 2012, we were permitted to launch our
generic versions of the 50, 150, 200, 300 and 400 mg strengths of
generic Seroquel XR®, on November 1, 2016, subject to FDA
final approval of our ANDA for those strengths. Our final FDA
approval followed the expiry of 180-day exclusivity periods granted
to the first filers of generic equivalents to the branded product,
which were shared by Par and Accord Healthcare
(“Accord”). The Company has manufactured and shipped
commercial quantities of all strengths of generic Seroquel XR®
to our marketing and distribution partner Mallinckrodt, and
Mallinckrodt launched all strengths in June 2017. There can be no
assurance that our generic Seroquel XR® in any of the 50, 150,
200, 300 and 400 mg strengths will be successfully
commercialized.
In
October 2016, we announced a license and commercial supply
agreement with Mallinckrodt, granting Mallinckrodt an exclusive
license to market, sell and distribute in the U.S. the following
licensed products which have either been launched (generic Seroquel
XR) or for which we have ANDAs filed with the FDA (the
“Mallinckrodt agreement”):
■
Quetiapine fumarate
extended-release tablets (generic Seroquel XR®) –
Approved and launched
■
Desvenlafaxine
extended-release tablets (generic Pristiq®) – ANDA Under
FDA Review
■
Lamotrigine
extended-release tablets (generic Lamictal® XR™) –
ANDA Under FDA Review
Under
the terms of the 10-year agreement, we received a non-refundable
upfront payment of $3 million in October 2016. In addition, the
agreement also provides for a long-term profit sharing arrangement
with respect to these licensed products (which includes up to $11
million in cost recovery payments that are payable on future sales
of licensed product). We have agreed to manufacture and supply the
licensed products exclusively for Mallinckrodt on a cost plus
basis. The Mallinckrodt agreement contains customary terms and
conditions for an agreement of this kind, and is subject to early
termination in the event we do not obtain FDA approvals of the
Mallinckrodt licensed products by specified dates, or pursuant to
any one of several termination rights of each party.
Our
goal is to leverage our proprietary technologies and know-how in
order to build a diversified portfolio of commercialized products
that generate revenue. We intend to do this by advancing our
products from the formulation stage through product development,
regulatory approval and manufacturing. We believe that full
integration of development and manufacturing will help maximize the
value of our drug delivery technologies, products and product
candidates. We also believe that out-licensing sales and marketing
to established organizations, when it makes economic sense to do
so, will improve our return from our products while allowing us to
focus on our core competencies. We expect expenditures in investing
activities for the purchase of production, laboratory and computer
equipment and the expansion of manufacturing and warehousing
capability to be higher as we prepare for the commercialization of
ANDAs, one NDA and one ANDS that are pending FDA and Health Canada
approval, respectively.
STRATEGY
Our
Hypermatrix™ technologies are central to the development and
manufacture of novel and generic controlled-release and
targeted-release oral solid dosage drugs. The Hypermatrix™
technologies are a multidimensional controlled-release drug
delivery platform that we believe can be applied to the efficient
development of a wide range of existing and new pharmaceuticals. We
believe that the flexibility of these technologies allows us to
develop complex drug delivery solutions within an
industry-competitive timeframe. Based on this technology platform,
we have developed several drug delivery systems and a pipeline of
products (some of which have received FDA approval) and product
candidates in various stages of development, including ANDAs filed
with the FDA (and one ANDS filed with Health Canada) and one NDA
filing, in therapeutic areas that include neurology,
cardiovascular, GIT, diabetes and pain. Certain, but not all, of
the products in our pipeline may be developed from time to time for
third parties pursuant to drug development agreements with those
third parties, under which our commercialization partner generally
pays certain of the expenses of development, sometimes makes
certain milestone payments to us and receives a share of revenues
or profits if the drug is developed successfully to completion, the
control of which is generally in the discretion of our drug
development partner.
The
principal focus of our development activities previously targeted
difficult-to-develop controlled-release generic drugs which follow
an ANDA regulatory path. Our current development effort is
increasingly directed towards improved difficult-to-develop
controlled-release drugs which follow an NDA 505(b)(2) regulatory
pathway. We have increased our research and development
(“R&D”) emphasis towards specialty new product
development, facilitated by the 505(b)(2) regulatory pathway, by
advancing the product development program for both Oxycodone ER and
RegabatinTM. The technology
that is central to our abuse deterrent formulation of our Oxycodone
ER is the novel Point of Divergence Drug Delivery System
(“nPODDDS™”). nPODDDS™ is designed to
provide for certain unique drug delivery features in a product.
These include the release of the active substance to show a
divergence in a dissolution and/or bioavailability profile. The
divergence represents a point or a segment in a release timeline
where the release rate, represented by the slope of the curve,
changes from an initial rate or set of rates to another rate or set
of rates, the former representing the usually higher rate of
release shortly after ingesting a dose of the drug, and the latter
representing the rate of release over a later and longer period of
time, being more in the nature of a controlled-release or sustained
action. It is applicable for the delivery of opioid analgesics in
which it is desired to discourage common methods of tampering
associated with misuse and abuse of a drug, and also dose dumping
in the presence of alcohol. It can potentially retard tampering
without interfering with the bioavailability of the
product.
In
addition, our Paradoxical OverDose Resistance Activating System
(“PODRAS™”) delivery technology was initially
introduced to enhance our Oxycodone ER (abuse deterrent oxycodone
hydrochloride extended release tablets) product candidate. The
PODRASTM
delivery technology platform was designed to prevent overdose when
more pills than prescribed are swallowed intact. Preclinical
studies of prototypes of oxycodone with PODRAS technology suggest
that, unlike other third-party abuse-deterrent oxycodone products
in the marketplace, if more tablets than prescribed are
deliberately or inadvertently swallowed, the amount of drug active
released over 24 hours may be substantially less than expected.
However, if the prescribed number of pills is swallowed, the drug
release should be as expected. Certain aspects of our PODRAS
technology are covered by U.S. Patent Nos. 9,522,119, 9,700,515 and
9,700,516 and Canadian Patent No. 2,910,865 issued by the U.S.
Patent and Trademark Office and the Canadian Intellectual Property
Office in respect of “Compositions and Methods for Reducing
Overdose” in December 2016 and July 2017. The issuance of
these patents provides us with the opportunity to accelerate our
PODRAS™ development plan over the next year by pursuing proof
of concept studies in humans. We intend to incorporate this
technology in an alternate Oxycodone ER product
candidate.
The NDA
505(b)(2) pathway (which relies in part upon the FDA’s
findings for a previously approved drug) both accelerates
development timelines and reduces costs in comparison to NDAs for
new chemical entities. An advantage of our strategy for development
of NDA 505(b)(2) drugs is that our product candidates can, if
approved for sale by the FDA, potentially enjoy an exclusivity
period which may provide for greater commercial opportunity
relative to the generic ANDA route.
The
market we operate in is created by the expiration of drug product
patents, challengeable patents and drug product exclusivity
periods. There are three ways that we employ our controlled-release
technologies, which we believe represent substantial opportunities
for us to commercialize on our own or develop products or
out-license our technologies and products:
●
For existing
controlled-release (once-a-day) products whose active
pharmaceutical ingredients (“APIs”) are covered by drug
molecule patents about to expire or already expired, or whose
formulations are covered by patents about to expire, already
expired or which we believe we do not infringe, we can seek to
formulate generic products which are bioequivalent to the branded
products. Our scientists have demonstrated a successful track
record with such products, having previously developed several drug
products which have been commercialized in the U.S. by their former
employer/clients. The regulatory pathway for this approach requires
ANDAs for the U.S. and ANDSs for Canada.
●
For branded
immediate-release (multiple-times-per-day) drugs, we can formulate
improved replacement products, typically by developing new,
potentially patentable, controlled-release once-a-day drugs. Among
other out-licensing opportunities, these drugs can be licensed to
and sold by the pharmaceutical company that made the original
immediate-release product. These can potentially protect against
revenue erosion in the brand by providing a clinically attractive
patented product that competes favorably with the generic
immediate-release competition that arises on expiry of the original
patent(s). The regulatory pathway for this approach requires NDAs
via a 505(b)(2) application for the U.S. or corresponding pathways
for other jurisdictions where applicable.
●
Some of our
technologies are also focused on the development of abuse-deterrent
and overdose preventive pain medications. The growing abuse and
diversion of prescription “painkillers”, specifically
opioid analgesics, is well documented and is a major health and
social concern. We believe that our technologies and know-how are
aptly suited to developing abuse-deterrent pain medications. The
regulatory pathway for this approach requires NDAs via a 505(b)(2)
application for the U.S. or corresponding pathways for other
jurisdictions where applicable.
We
intend to collaborate in the development and/or marketing of one or
more products with partners, when we believe that such
collaboration may enhance the outcome of the project. We also plan
to seek additional collaborations as a means of developing
additional products. We believe that our business strategy enables
us to reduce our risk by (a) having a diverse product portfolio
that includes both branded and generic products in various
therapeutic categories, and (b) building collaborations and
establishing licensing agreements with companies with greater
resources thereby allowing us to share costs of development and to
improve cash-flow. There can be no assurance that we will be able
to enter into additional collaborations or, if we do, that such
arrangements will be commercially viable or
beneficial.
OUR DRUG DELIVERY TECHNOLOGIES
HypermatrixTM
Our
scientists have developed drug delivery technology systems, based
on the Hypermatrix™ platform, that facilitate
controlled-release delivery of a wide range of pharmaceuticals.
These systems include several core technologies, which enable us to
flexibly respond to a wide range of drug attributes and patient
requirements, producing a desired controlled-release effect. Our
technologies have been incorporated in drugs manufactured and sold
by major pharmaceutical companies.
This
group of drug delivery technology systems is based upon the drug
active ingredient (“drug active”) being imbedded in,
and an integral part of, a homogeneous (uniform), core and/or
coatings consisting of one or more polymers which affect the
release rates of drugs, other excipients (compounds other than the
drug active), such as for instance lubricants which control
handling properties of the matrix during fabrication, and the drug
active itself. The Hypermatrix™ technologies are the core of
our current marketing efforts and the technologies underlying our
existing development agreements.
nPODDDSTM
In
addition to continuing efforts with Hypermatrix™ as a core
technology, our scientists continue to pursue novel research
activities that address unmet needs. Oxycodone ER (abuse deterrent
oxycodone hydrochloride extended release tablets) is an NDA
candidate with a unique long acting oral formulation of oxycodone
intended to treat moderate-to-severe pain. The formulation is
intended to present a significant barrier to tampering when
subjected to various forms of physical and chemical manipulation
commonly used by abusers. It is also designed to prevent dose
dumping when inadvertently co-administered with alcohol. The
technology that supports our abuse deterrent formulation of
oxycodone is the nPODDDS™ Point of Divergence Drug Delivery
System. The use of nPODDDS™ does not interfere with the
bioavailability of oxycodone. We intend to apply the nPODDDS™
technology platforms to other extended release opioid drug
candidates (e.g., oxymorphone, hydrocodone, hydromorphone and
morphine) utilizing the 505(b)(2) regulatory pathway.
PODRASTM
Our
Paradoxical OverDose Resistance Activating System (PODRAS™)
delivery technology is designed to prevent overdose when more pills
than prescribed are swallowed intact. Preclinical studies of
prototypes of oxycodone with PODRAS technology suggest that, unlike
other third-party abuse-deterrent oxycodone products in the
marketplace, if more tablets than prescribed are deliberately or
inadvertently swallowed, the amount of drug active released over 24
hours may be substantially less than expected. However, if the
prescribed number of pills is swallowed, the drug release should be
as expected. We are currently working on an alternate Oxycodone ER
product candidate incorporating our PODRAS™ delivery
technology. In April 2015, the FDA published Guidance for Industry: Abuse-Deterrent
Opioids — Evaluation and Labeling, which cited the
need for more efficacious abuse-deterrence technology. In this
Guidance, the FDA stated, “opioid products are often
manipulated for purposes of abuse by different routes of
administration or to defeat extended-release properties, most
abuse-deterrent technologies developed to date are intended to make
manipulation more difficult or to make abuse of the manipulated
product less attractive or less rewarding. It should be noted that
these technologies have not yet proven successful at deterring the
most common form of abuse—swallowing a number of intact
capsules or tablets to achieve a feeling of euphoria.” The
FDA reviewed our request for Fast Track designation for our abuse
deterrent Oxycodone ER development program incorporating
PODRAS™, and in May 2015 notified us that the FDA had
concluded that we met the criteria for Fast Track designation. Fast
Track is a designation assigned by the FDA in response to an
applicant’s request which meets FDA criteria. The designation
mandates the FDA to facilitate the development and expedite the
review of drugs intended to treat serious or life threatening
conditions and that demonstrate the potential to address unmet
medical needs.
In
December 2016 and July 2017, we obtained U.S. Patent Nos.
9,522,119, 9,700,515 and 9,700,516 and Canadian Patent No.
2,910,865 were issued by the U.S. Patent and Trademark Office and
the Canadian Intellectual Property Office in respect of
“Compositions and Methods for Reducing Overdose”. The
issued patents cover aspects of the PODRAS™ delivery
technology. The issuance of these patents represents a significant
advance in our abuse deterrence technology platform. The
PODRAS™ platform has the potential to positively
differentiate our technology from others of which we are aware, and
may represent an important step toward addressing the FDA’s
concern over the ingestion of a number of intact pills or tablets.
In addition to its use with opioids, the PODRASTM platform is
potentially applicable to a wide range of drug products, inclusive
of over-the-counter drugs, that are intentionally or inadvertently
abused and cause harm by overdose to those who ingest them. We
intend to incorporate this technology in an alternate Oxycodone ER
product candidate. We intend to apply the PODRAS™ technology
platforms to other extended release opioid drug candidates (e.g.,
oxymorphone, hydrocodone, hydromorphone and morphine) utilizing the
505(b)(2) regulatory pathway.
PRODUCTS AND
PRODUCT CANDIDATES
The
table below shows the present status of our ANDA, ANDS and NDA
products and product candidates that have been disclosed to the
public.
Generic Name
|
Brand
|
Indication
|
Stae of Development
(1)
|
Regulatory Pathway
|
Market Size (in millions)(2)
|
Rights(3)
|
Dexmethylphenidate hydrochloride extended-release
capsules
|
Focalin XR®
|
Attention deficit
hyperactivity disorder
|
Received final
approval for 5, 10,15, 20, 25, 30, 35 and 40 mg strengths from
FDA(4)
|
ANDA
|
$802
|
Intellipharmaceutics
and Par
|
Levetiracetam extended-release tablets
|
Keppra XR®
|
Partial onset
seizures for epilepsy
|
Received final
approval for the 500 and 750 mg strengths from FDA
|
ANDA
|
$134
|
Intellipharmaceutics
|
Venlafaxine hydrochloride extended-release capsules
|
Effexor
XR®
|
Depression
|
ANDA application
for commercialization approval for 3 strengths under review by
FDA
|
ANDA
|
$693
|
Intellipharmaceutics
|
Pantoprazole sodium delayed- release tablets
|
Protonix®
|
Conditions
associated with gastroesophageal reflux diseas
|
ANDA application
for commercialization approval for 2 strengths under review by
FDA
|
ANDA
|
$337
|
Intellipharmaceutics
|
Metformin hydrochloride extended-release tablets
|
Glucophage® XR
|
Management of type
2 diabetes
|
Received final
approval for 500 and 750 mg strengths from FDA
|
ANDA
|
$528
(500
and 700 mg only)
|
Intellipharmaceutics
|
Quetiapine fumarate extended-release tablets
|
Seroquel XR®
|
Schizophrenia,
bipolar disorder & major depressive disorder
|
Received final FDA
approval for all 5 strengths. ANDS under review by Health
Canada
|
ANDA/
ANDS
|
$557
|
Intellipharmaceutics
and Mallinckrodt
|
Lamotrigine extended-release tablets
|
Lamictal® XR™
|
Anti-convulsant
for epilepsy
|
ANDA application
for commercialization approval for 6 strengths under review by
FDA
|
ANDA
|
$531
|
Intellipharmaceutics
and Mallinckrodt
|
Desvenlafaxine extended-release tablets
|
Pristiq®
|
Depression
|
ANDA application
for commercialization approval for 2 strengths under review by
FDA
|
ANDA
|
$582
|
Intellipharmaceutics
and Mallinckrodt
|
Trazodone hydrochloride extended-release tablets
|
Oleptro™
|
Depression
|
ANDA application
for commercialization approval for 2 strengths under review by
FDA
|
ANDA
|
$1
|
Intellipharmaceutics
|
Carvedilol phosphate extended- release capsules
|
Coreg CR®
|
Heart failure,
hypertension
|
Late-stage
development
|
ANDA
|
$214
|
Intellipharmaceutics
|
Oxycodone hydrochloride controlled-release capsules
|
OxyContin®
|
Pain
|
NDA application
accepted February 2017 and under review by FDA
|
NDA
505(b)(2)
|
$1,940
|
Intellipharmaceutics
|
Pregabalin extended-release capsules
|
Lyrica®
|
Neuropathic
pain
|
Investigational
New Drug (“IND”) application submitted in August
2015
|
NDA
505(b)(2)
|
$4,578
|
Intellipharmaceutics
|
Ranolazine extended-release tablets
|
Ranexa®
|
Chronic
angina
|
ANDA application
for commercialization approval for 2 strengths under review by
FDA
|
ANDA
|
$926
|
Intellipharmaceutics
|
Notes:
(1)
There can be no
assurance as to when, or if at all, the FDA or Health Canada will
approve any product candidate for sale in the U.S. or Canadian
markets.
(2)
Represents sales
for all strengths, unless otherwise noted, for the 12 months ended
August 2017 in the U.S., including sales of generics in TRx MBS
Dollars, which represents projected new and refilled prescriptions
representing a standardized dollar metric based on
manufacturer’s published catalog or list prices to
wholesalers, and does not represent actual transaction prices and
does not include prompt pay or other discounts, rebates or
reductions in price. Source: Symphony Health Solutions Corporation.
The information attributed to Symphony Health Solutions Corporation
herein is provided as is, and Symphony makes no representation
and/or warranty of any kind, including but not limited to, the
accuracy and/or completeness of such information.
(3)
For unpartnered
products, we are exploring licensing agreement opportunities or
other forms of distribution. While we believe that licensing
agreements are possible, there can be no assurance that any can be
secured.
(4)
Includes a Company
ANDA final approval for our 15 and 30 mg strengths, and a Par ANDA
final approval for their 5, 10, 15, 20, 25, 30, 35 and 40 mg
strengths. Profit sharing payments to us under the Par agreement
are the same irrespective of the ANDA owner.
We
typically select products for development that we anticipate could
achieve FDA or Health Canada approval for commercial sales several
years in the future. However, the length of time necessary to bring
a product to the point where the product can be commercialized can
vary significantly and depends on, among other things, the
availability of funding, design and formulation challenges, safety
or efficacy, patent issues associated with the product, and FDA and
Health Canada review times.
Dexmethylphenidate
Hydrochloride – Generic Focalin
XR®
(a registered trademark of
the brand manufacturer)
Dexmethylphenidate
hydrochloride, a Schedule II restricted product (drugs with a high
potential for abuse) in the U.S., is indicated for the treatment of
attention deficit hyperactivity disorder. In November 2005, we
entered into the Par agreement pursuant to which we granted Par an
exclusive, royalty-free license to make and distribute in the U.S.
all of our FDA approved strengths of our generic Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules for a
period of 10 years from the date of commercial launch (which was
November 19, 2013). We retain the right to make and distribute all
strengths of the generic product outside of the U.S. Calendar
quarterly profit-sharing payments for its U.S. sales under the
Company ANDA are payable by Par to us as calculated pursuant to the
Par agreement. Within the purview of the Par agreement, Par also
applied for and owns an ANDA pertaining to all marketed strengths
of generic Focalin XR® (the “Par ANDA”), and is
now approved by the FDA to market generic Focalin XR® capsules
in all marketed strengths in the U.S. As with the Company ANDA,
calendar quarterly profit-sharing payments are payable by Par to us
for its U.S. sales of generic Focalin XR® under the Par ANDA
as calculated pursuant to the Par agreement.
We
received final approval from the FDA in November 2013 under the
Company ANDA to launch the 15 and 30 mg strengths of our generic
Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules.
Commercial sales of these strengths were launched immediately by
our commercialization partner in the U.S., Par. Our 5, 10, 20 and
40 mg strengths were also then tentatively FDA approved, subject to
the right of Teva Pharmaceuticals USA, Inc. (“Teva”) to
180 days of generic exclusivity from the date of first launch of
such products. Teva launched its own 5, 10, 20 and 40 mg strengths
of generic Focalin XR® capsules on
November 11, 2014, February 2, 2015, June 22, 2015 and November 19,
2013, respectively. In January 2017, Par launched the 25 and 35 mg
strengths of its generic Focalin XR® capsules in the
U.S., and in May 2017, Par launched the 10 and 20 mg strengths,
complementing the 15 and 30 mg strengths of our generic Focalin
XR®
marketed by Par. The FDA recently had granted final approval under
the Par ANDA (as defined below) for its generic Focalin
XR®
capsules in the 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths. We
believe Par is preparing to launch the remaining 5 and 40 mg
strengths in the near future. As the first filer of an ANDA for
generic Focalin XR® in the 25 and
35 mg strengths, Par had 180 days of U.S. generic marketing
exclusivity for those strengths. There can be no assurance as to
when or if any further launches will occur for the remaining
strengths, or if they will be successfully
commercialized.
Levetiracetam – Generic Keppra XR® (a registered trademark of the brand
manufacturer)
We
received final approval from the FDA in February 2016 for the 500
and 750 mg strengths of our generic Keppra XR® (levetiracetam
extended-release) tablets. Keppra XR®, and the drug active
levetiracetam, are indicated for use in the treatment of partial
onset seizures associated with epilepsy. The Company is aware that
several other generic versions of this product are currently
available and serve to limit the overall market opportunity. We are
actively exploring the best approach to maximize the commercial
returns from this approval. There can be no assurance that the
Company's generic Keppra XR® for the 500 and 750 mg strengths
will be successfully commercialized.
Metformin hydrochloride – Glucophage® XR
(a registered trademark of the
brand manufacturer)
We
received final approval from the FDA in February 2017 for the 500
and 750 mg strengths of our generic Glucophage® XR (metformin
hydrochloride extended release) tablets. Glucophage® XR, and
the drug active metformin, are indicated for use in the management
of type 2 diabetes treatment. The Company is aware that several
other generic versions of this product are currently available and
serve to limit the overall market opportunity. We are continuing to
evaluate options to realize commercial returns from this new
approval. There can be no assurance that our metformin
extended-release tablets for the 500 and 750 mg strengths will be
successfully commercialized.
Oxycodone ER (Abuse Deterrent Oxycodone Hydrochloride
Extended-Release Tablets, formerly known as RexistaTM)
One of
our non-generic products under development is our Oxycodone ER
(abuse deterrent oxycodone hydrochloride extended release tablets)
product candidate, intended as an abuse and alcohol-deterrent
controlled-release oral formulation of oxycodone hydrochloride for
the relief of pain. Our Oxycodone ER is a new drug candidate, with
a unique long acting oral formulation of oxycodone intended to
treat moderate-to-severe pain when a continuous, around the clock
opioid analgesic is needed for an extended period of time. The
formulation is intended to present a significant barrier to
tampering when subjected to various forms of physical and chemical
manipulation commonly used by abusers. It is also designed to
prevent dose dumping when inadvertently co-administered with
alcohol. Dose dumping is the rapid release of an active ingredient
from a controlled-release drug into the blood stream that can
result in increased toxicity, side effects, and a loss of efficacy.
Dose dumping can result by consuming the drug through crushing,
taking with alcohol, extracting with other beverages, vaporizing or
injecting. In addition, when crushed or pulverized and hydrated,
the proposed extended release formulation is designed to coagulate
instantaneously and entrap the drug in a viscous hydrogel, which is
intended to prevent syringing, injecting and snorting. Our
Oxycodone ER formulation is difficult to abuse through the
application of heat or an open flame, making it difficult to inhale
the active ingredient from burning. Our Oxycodone ER formulation
contains a blue dye that is emitted once the tablet is tampered
with or crushed. This blue dye may act as a deterrent if abused
orally or via the intra-nasal route and may also serve as an early
warning mechanism to flag potential misuse or abuse.
In
March 2015, we announced the results of three definitive open
label, blinded, randomized, cross-over, Phase I pharmacokinetic
clinical trials in which our Oxycodone ER was compared to the
existing branded drug OxyContin® under single dose fasting,
single dose steady-state fasting and single dose fed conditions in
healthy volunteers. We had reported that the results from all three
studies showed that Oxycodone ER met the bioequivalence criteria
(90% confidence interval of 80% to 125%) for all matrices, i.e., on
the measure of maximum plasma concentration or Cmax, on the measure
of area under the curve time (AUCt) and on the
measure of area under the curve infinity (AUCinf).
In May
2015, the FDA provided us with notification regarding our IND
submission for Oxycodone ER indicating that we would not be
required to conduct Phase III studies if bioequivalence to
OxyContin® was demonstrated based on pivotal bioequivalence
studies.
In
January 2016, we announced that pivotal bioequivalence trials of
our Oxycodone ER, dosed under fasted and fed conditions, had
demonstrated bioequivalence to OxyContin® (oxycodone
hydrochloride) extended release tablets as manufactured and sold in
the U.S. by Purdue Pharma L.P. The study design was based on FDA
recommendations and compared the lowest and highest strengths of
exhibit batches of our Oxycodone ER to the same strengths of
OxyContin®. The results show that the ratios of the
pharmacokinetic metrics, Cmax, AUC0-t and
AUC0-f
for Oxycodone ER vs OxyContin®, are within the interval of 80%
- 125% required by the FDA with a confidence level exceeding 90%.
Having now demonstrated such bioequivalence, we believe we will not
be required to conduct Phase III studies although no assurance can
be given that we will not be required to conduct further studies
for Oxycodone ER. The FDA notification is significant as it
provides a basis for an accelerated development plan for our
Oxycodone ER product candidate, without the need for more costly
and time consuming Phase III studies.
In July
2016, we announced the results of a food effect study conducted on
our behalf for Oxycodone ER. The study design was a
randomized, one-treatment two periods, two sequences, crossover,
open label, laboratory-blind bioavailability study for Oxycodone ER
following a single 80 mg oral dose to healthy adults under fasting
and fed conditions. The study showed that Oxycodone ER can be
administered with or without a meal (i.e., no food effect).
Oxycodone ER met the bioequivalence criteria (90% confidence
interval of 80% to 125%) for all matrices, involving maximum plasma
concentration and area under the curve (i.e., Cmax ratio of
Oxycodone ER taken under fasted conditions to fed conditions, and
AUC metrics taken under fasted conditions to fed conditions). We
believe that Oxycodone ER is well differentiated from currently
marketed oral oxycodone extended release products.
In
November 2016, we filed an NDA seeking authorization to market our
Oxycodone ER in the 10, 15, 20, 30, 40, 60 and 80 mg strengths,
relying on the 505(b)(2) regulatory pathway which allowed us to
reference data from Purdue Pharma L.P.’s file for its
OxyContin® (extended release oxycodone hydrochloride). In
February 2017, the FDA accepted for filing our NDA, and set a
Prescription Drug User Fee Act (“PDUFA”) target action
date of September 25, 2017. Our submission is supported by pivotal
pharmacokinetic studies that demonstrated that Oxycodone ER is
bioequivalent to OxyContin®. The submission also includes
abuse-deterrent studies conducted to support abuse-deterrent label
claims related to abuse of the drug by various pathways, including
oral, intra-nasal and intravenous, having reference to the FDA's
"Abuse-Deterrent Opioids — Evaluation and Labeling" guidance
published in April 2015.
Our NDA
was filed under Paragraph IV of the Hatch-Waxman Act, as amended.
We certified to the FDA that we believed that our Oxycodone
ER product
candidate would not infringe any of the OxyContin® patents (as
defined below) listed in the Orange Book (as defined below), or
that such patents are invalid, and so notified all holders of the
subject patents of such certification. On April 7, 2017, we
received notice that the Purdue litigation plaintiffs (as defined
below) had commenced patent infringement proceedings (the
“Purdue litigation”) against us in the U.S. District
Court for the District of Delaware in respect of tour NDA filing
for Oxycodone ER, alleging that our Oxycodone ER product infringes
six (6) out of the sixteen (16) patents. The complaint seeks
injunctive relief as well as attorneys’ fees and costs and
such other and further relief as the Court may deem just and
proper. An answer and counterclaim have been filed. As a result of
the commencement of these legal proceedings, the FDA is stayed for
30 months from granting final approval to our Oxycodone ER product
candidate. That time period commenced on February 24, 2017, when
the Purdue litigation plaintiffs received notice of our
certification concerning the patents, and will expire on August 24,
2019, unless the stay is earlier terminated by a final declaration
of the courts that the patents are invalid, or are not infringed,
or the matter is otherwise settled among the parties. A trial date
for the Purdue litigation has been set for October 22, 2018. We are
confident that we do not infringe the subject patents, and will
vigorously defend against these claims.
In June
2017, we announced that a FDA Advisory Committee meeting was
scheduled for July 26, 2017 to review our NDA for Oxycodone ER
abuse-deterrent oxycodone hydrochloride extended release tablets.
The submission requests that our Oxycodone ER product candidate
include product label claims to support the inclusion of language
regarding abuse-deterrent properties for the intravenous route of
administration.
In July
2017, the Company announced that the FDA Advisory Committee voted
22 to 1 in finding that the Company’s NDA for Oxycodone ER
abuse-deterrent oxycodone hydrochloride extended release tablets
should not be approved at this time. The committees also voted 19
to 4 that the Company has not demonstrated that Oxycodone ER has
properties that can be expected to deter abuse by the intravenous
route of administration, and 23 to 0 that there are not sufficient
data for Oxycodone ER to support inclusion of language regarding
abuse-deterrent properties in the product label for the intravenous
route of administration. The committees expressed a desire to
review the additional safety and efficacy data for Oxycodone ER
that may be obtained from human abuse potential studies for the
oral and intranasal routes of administration.
In
September 2017 the Company received a CRL from the FDA for the
Oxycodone ER NDA. In its CRL, the FDA provided certain
recommendations and requests for information, including that
Intellipharmaceutics complete the relevant Category 2 and Category
3 studies to assess the abuse-deterrent properties of Oxycodone ER
by the oral and nasal routes of administration. The FDA also
requested additional information related to the inclusion of the
blue dye in the Oxycodone ER formulation, which is intended to
deter abuse. The FDA also requested that Intellipharmaceutics
submit an alternate proposed proprietary name for Oxycodone ER. The
FDA determined that it cannot approve the application in its
present form. Intellipharmaceutics has been given one year to
respond to the CRL, and can request additional time if necessary.
The Company announced in September 2017 that it had already planned
the additional Category 2 and Category 3 studies the FDA has
requested and it does not expect that the conduct of these studies
will impact the Company’s anticipated commercialization
timeline for Oxycodone ER.
There
can be no assurance that the studies will be adequate, that we will
not be required to conduct further studies for Oxycodone ER, that
the FDA will approve any of the Company’s requested
abuse-deterrence label claims or that the FDA will ultimately
approve our NDA for the sale of Oxycodone ER in the U.S. market, or
that it will ever be successfully commercialized.
Quetiapine fumarate extended-release tablets - Generic Seroquel
XR® (a registered
trademark of the brand manufacturer)
In
October 2016, we received tentative approval from the FDA for our
ANDA for quetiapine fumarate extended-release tablets in the 50,
150, 200, 300 and 400 mg strengths, and in May 2017, our ANDA
received final FDA approval for all of these strengths. Our
approved product is a generic equivalent for the corresponding
strengths of the branded product Seroquel XR® sold in the U.S.
by AstraZeneca. Pursuant to a settlement agreement between us and
AstraZeneca dated July 30, 2012, we were permitted to launch our
generic versions of the 50, 150, 200, 300 and 400 mg strengths of
generic Seroquel XR®, on November 1, 2016, subject to FDA
final approval of our ANDA for those strengths. Our final FDA
approval followed the expiry of 180-day exclusivity periods granted
to the first filers of generic equivalents to the branded product,
which were shared by Par and Accord. The Company manufactured and
shipped commercial quantities of all strengths of generic Seroquel
XR® to our marketing and distribution partner Mallinckrodt,
and Mallinckrodt launched all strengths in June 2017. There can be
no assurance that our generic Seroquel XR® in any of the 50,
150, 200, 300 and 400 mg strengths will be successfully
commercialized.
Regabatin™ XR (Pregabalin
Extended-Release)
Another
Intellipharmaceutics non-generic controlled-release product under
development is Regabatin™ XR, pregabalin extended-release
capsules. Pregabalin is indicated for the management of neuropathic
pain associated with diabetic peripheral neuropathy, postherpetic
neuralgia, spinal cord injury and fibromyalgia. A
controlled-release version of pregabalin should reduce the number
of doses patients take, which could improve patient compliance, and
therefore possibly enhance clinical outcomes. Lyrica®
pregabalin, twice-a-day ("BID") dosage and three-times-a-day
("TID") dosage, are drug products marketed in the U.S. by Pfizer
Inc. There is no controlled-release formulation on the market at
this time. A controlled-release version of pregabalin should reduce
the number of doses patients take, potentially improving patient
compliance, and therefore potentially improving clinical
outcomes.
In
2014, we conducted and analyzed the results of six Phase I clinical
trials involving a twice-a-day formulation and a once-a-day
formulation. For formulations directed to certain indications which
include fibromyalgia, the results suggested that Regabatin™
XR 82.5 mg BID dosage was comparable in bioavailability to
Lyrica® 50 mg (immediate-release pregabalin) TID dosage. For
formulations directed to certain other indications which include
neuropathic pain associated with diabetic peripheral neuropathy,
the results suggested that Regabatin™ XR 165 mg once-a-day
dosage was comparable in bioavailability to Lyrica® 75 mg BID
dosage.
In
March 2015, the FDA accepted a Pre-Investigational New Drug
(“Pre-IND”) meeting request for our once-a-day
Regabatin™ XR non-generic controlled release version of
pregabalin under the NDA 505(b)(2) regulatory pathway, with a view
to possible commercialization in the U.S. at some time following
the December 30, 2018 expiry of the patent covering the pregabalin
molecule. Regabatin™ XR is based on our controlled release
drug delivery technology platform which utilizes the symptomatology
and chronobiology of fibromyalgia in a formulation intended to
provide a higher exposure of pregabalin during the first 12 hours
of dosing. Based on positive feedback and guidance from the FDA, we
submitted an IND application for RegabatinTM XR in August 2015.
The FDA completed its review of the IND application and provided
constructive input that we will use towards further development of
the program.
There
can be no assurance that any additional Phase I or other clinical
trials we conduct will meet our expectations, that we will have
sufficient capital to conduct such trials, that we will be
successful in submitting an NDA 505(b)(2) filing with the FDA, that
the FDA will approve this product candidate for sale in the U.S.
market, or that it will ever be successfully
commercialized.
SELECTED FINANCIAL INFORMATION
|
For the three months ended
|
For the nine months ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
Revenue:
|
1,189,739
|
554,925
|
4,426,617
|
1,677,906
|
Expenses:
|
3,181,755
|
2,586,001
|
9,807,041
|
7,709,212
|
Loss
from operations
|
(2,550,314)
|
(2,110,156)
|
(6,346,504)
|
(6,230,273)
|
Loss
per common share, basic and diluted
|
(0.08)
|
(0.07)
|
(0.21)
|
(0.24)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As at
|
August 31, 2017
|
November 30, 2016
|
|
|
|
(UNAUDITED)
|
(AUDITED)
|
|
|
|
$
|
$
|
|
|
Cash
|
735,156
|
4,144,424
|
|
|
Total
assets
|
6,658,374
|
7,974,689
|
|
|
|
|
|
|
|
Convertible
debenture
|
1,316,516
|
1,494,764
|
|
|
Total
liabilities
|
7,451,145
|
6,858,425
|
|
|
Shareholders'
(deficit) equity
|
(792,771)
|
1,116,264
|
|
|
Total
liabilities and shareholders equity
|
6,658,374
|
7,974,689
|
|
|
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
We have
identified the following accounting policies that we believe
require application of management’s most significant
judgments, often requiring the need to make estimates about the
effect of matters that are inherently uncertain and may change in
subsequent periods.
Disclosure
regarding our ability to continue as a going concern is included in
Note 1 to our condensed unaudited interim consolidated financial
statements for the three and nine months ended August 31,
2017.
Use of Estimates
The
preparation of the condensed unaudited interim consolidated
financial statements in conformity with U.S. GAAP requires
management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenue and expenses during
the period. Actual results could differ from those
estimates.
Areas
where significant judgment is involved in making estimates are: the
determination of the functional currency; the fair values of
financial assets and liabilities; the determination of units of
accounting for revenue recognition; the accrual of licensing and
milestone revenue; and forecasting future cash flows for assessing
the going concern assumption.
Revenue recognition
The
Company accounts for revenue in accordance with the provisions of
ASC topic 605 Revenue Recognition. The Company earns revenue from
non-refundable upfront fees, milestone payments upon achievement of
specified research or development, exclusivity milestone payments
and licensing payments on sales of resulting products and other
incidental services. Revenue is realized or realizable and earned
when persuasive evidence of an arrangement exists, delivery has
occurred or services have been rendered, the price to the customer
is fixed or determinable, and collectability is reasonably assured.
From time to time, the Company enters into transactions that
represent multiple-element arrangements. Management evaluates
arrangements with multiple deliverables to determine whether the
deliverables represent one or more units of accounting for the
purpose of revenue recognition.
A
delivered item is considered a separate unit of accounting if the
delivered item has stand-alone value to the customer, the fair
value of any undelivered items can be reliably determined, and the
delivery of undelivered items is probable and substantially in the
Company's control.
The
relevant revenue recognition accounting policy is applied to each
separate unit of accounting.
Licensing
The
Company recognizes revenue from the licensing of the Company's drug
delivery technologies, products and product candidates. Licensing
revenue is recognized as earned in accordance with the contract
terms when the amounts can be reasonably estimated and
collectability is reasonably assured.
The
Company has a license and commercialization agreement with Par.
Under the exclusive territorial license rights granted to Par, the
agreement requires that Par manufacture, promote, market, sell and
distribute the product. Licensing revenue amounts receivable by the
Company under this agreement are calculated and reported to the
Company by Par, with such amounts generally based upon net product
sales and net profit which include estimates for chargebacks,
rebates, product returns, and other adjustments. Licensing revenue
payments received by the Company from Par under this agreement are
not subject to further deductions for chargebacks, rebates, product
returns, and other pricing adjustments. Based on this arrangement
and the guidance per ASC topic 605, the Company records licensing
revenue as earned in the condensed unaudited interim consolidated
statements of operations and comprehensive loss.
The
Company also has a license and commercial supply agreement with
Mallinckrodt which provides Mallinckrodt an exclusive license to
market sell and distribute in the U.S. three drug product
candidates for which the Company has ANDAs filed with the FDA, one
of which (the Company’s generic Seroquel XR®) received
final approval from the FDA in 2017. Under the terms of this
agreement, the Company is responsible for the manufacture of
approved products for subsequent sale by Mallinckrodt in the U.S.
market. Following receipt of final FDA approval for its generic
Seroquel XR®, the Company began shipment of manufactured
product to Mallinckrodt. Licensing revenue in respect of
manufactured product is reported as revenue in accordance with ASC
topic 605. Once product is sold by Mallinckrodt, the Company
receives downstream licensing revenue amounts calculated and
reported by Mallinckrodt, with such amounts generally based upon
net product sales and net profit which includes estimates for
chargebacks, rebates, product returns, and other adjustments. Such
downstream licensing revenue payments received by the Company under
this agreement are not subject to further deductions for
chargebacks, rebates, product returns, and other pricing
adjustments. Based on this agreement and the guidance per ASC topic
605, the Company records licensing revenue as earned in the
condensed unaudited interim consolidated statements of operations
and comprehensive loss.
Milestones
The
milestone method recognizes revenue on substantive milestone
payments in the period the milestone is achieved. Milestones are
considered substantive if all of the following conditions are met:
(i) the milestone is commensurate with either the vendor’s
performance to achieve the milestone or the enhancement of the
value of the delivered item or items as a result of a specific
outcome resulting from the vendor’s performance to achieve
the milestone; (ii) the milestone relates solely to past
performance; and (iii) the milestone is reasonable relative to all
of the deliverables and payment terms within the arrangement.
Non-substantive milestone payments that might be paid to the
Company based on the passage of time or as a result of a
partner’s performance are allocated to the units of
accounting within the arrangement; they are recognized as revenue
in a manner similar to those units of accounting.
Research and development
Under
arrangements where the license fees and R&D activities can be
accounted for as a separate unit of accounting, non-refundable
upfront license fees are deferred and recognized as revenue on a
straight-line basis over the expected term of the Company's
continued involvement in the R&D process.
Deferred revenue
Deferred
revenue represents the funds received from clients, for which the
revenues have not yet been earned, as the milestones have not been
achieved, or in the case of upfront fees for drug development,
where the work remains to be completed. During the fiscal quarter
ended November 30, 2016, the Company received an up-front payment
of $3,000,000 from Mallinckrodt pursuant to the Mallinckrodt
license and commercial supply agreement, and initially recorded it
as deferred revenue, as it did not meet the criteria for
recognition. For the three and nine months ended August 31, 2017,
the Company recognized $75,000 and $225,000 of revenue based on a
straight-line basis over the expected term of the Mallinckrodt
agreement of 10 years. In 2015, the Company received an up-front
payment of $150,000 from Teva which it continues to record as
deferred revenue as the criteria for revenue recognition have not
been met.
As of
August 31, 2017, the Company has recorded a deferred revenue
balance of $2,887,500 (November 30, 2016 -$3,112,500) relating to
the underlying contracts, of which $450,000 is considered a current
liability.
Other incidental services
Incidental
services which the Company may provide from time to time include,
consulting advice provided to other organizations regarding FDA
standards. Revenue is earned and realized when all of the following
conditions are met: (i) there is persuasive evidence of an
arrangement; (ii) service has been rendered; (iii) the sales price
is fixed or determinable; and (iv) collectability is reasonably
assured.
Research and development costs
Research
and development costs related to continued R&D programs are
expensed as incurred in accordance with ASC topic 730. However,
materials and equipment are capitalized and amortized over their
useful lives if they have alternative future uses.
Inventory
Inventories
comprise raw material, work in process, and finished goods, which
are valued at the lower of cost or market, on a first-in, first-out
basis. Cost for work in process and finished goods inventories
includes materials, direct labor, and an allocation of
manufacturing overhead. Market for raw materials is replacement
cost, and for work in process and finished goods is net realizable
value. The Company evaluates the carrying value of inventories on a
regular basis, taking into account such factors as historical and
anticipated future sales compared with quantities on hand, the
price the Company expects to obtain for products in their
respective markets compared with historical cost and the remaining
shelf life of goods on hand. As of August 31, 2017, the Company had
inventories of $187,416 relating to the Company’s generic
Seroquel XR® product. The recoverability of the cost of
pre-launch inventories with a limited shelf life is evaluated based
on the specific facts and circumstances surrounding the timing of
the anticipated product launch.
Translation of foreign currencies
Transactions
denominated in currencies other than the Company and its wholly
owned operating subsidiaries’ functional currencies, the
monetary assets and liabilities are translated at the period end
rates. Revenue and expenses are translated at rates of exchange
prevailing on the transaction dates. All of the exchange gains or
losses resulting from these other transactions are recognized in
the consolidated statements of operations and comprehensive
loss.
The
Company’s functional and reporting currency is the U.S.
dollar.
Future accounting pronouncements
In May
2014, the FASB issued Accounting Standards Update
(“ASU”) No. 2014-09, Revenue from Contracts with
Customers, requiring an entity to recognize the amount of revenue
to which it expects to be entitled for the transfer of promised
goods or services to customers. The updated standard will replace
most existing revenue recognition guidance in U.S. GAAP when it
becomes effective. In March 2016, the FASB issued ASU No. 2016-08
to clarify the implementation guidance on considerations of whether
an entity is a principal or an agent, impacting whether an entity
reports revenue on a gross or net basis. In April 2016, the FASB
issued ASU No. 2016-10 to clarify guidance on identifying
performance obligations and the implementation guidance on
licensing. In May 2016, the FASB issued amendments ASU No. 2016-11
and 2016-12 to amend certain aspects of the new revenue guidance
(including transition, collectability, noncash consideration and
the presentation of sales and other similar taxes) and provided
certain practical expedients. The guidance is effective for annual
reporting periods beginning after December 15, 2017 (including
interim reporting periods). Early adoption is permitted but not
before the annual reporting period (and interim reporting period)
beginning January 1, 2017. Entities have the option of using either
a full retrospective or a modified approach to adopt the guidance.
The Company is in the process of evaluating the amendments to
determine if they have a material impact on the Company’s
financial position, results of operations, cash flows or
disclosures.
In June
2014, the FASB issued ASU No. 2014-12 in response to the consensus
of the Emerging Issues Task Force on EITF Issue 13-D. The ASU
clarifies that entities should treat performance targets that can
be met after the requisite service period of a share-based payment
award as performance conditions that affect vesting. Therefore, an
entity would not record compensation expense (measured as of the
grant date without taking into account the effect of the
performance target) related to an award for which transfer to the
employee is contingent on the entity’s satisfaction of a
performance target until it becomes probable that the performance
target will be met. No new disclosures are required under the ASU.
The ASU’s guidance is effective for all entities for
reporting periods (including interim periods) beginning after
December 15, 2015. Early adoption is permitted. The Company does
not expect the adoption of the amendments to have a material impact
on the Company’s financial position, results of operations or
cash flows. In March 2016, the FASB issued new guidance ASU No.
2016-09 which simplifies several aspects of the accounting for
employee share-based payment transactions, including the income tax
consequences, classification of awards as either equity or
liabilities, accounting for forfeitures, and classification on the
statement of cash flows. The guidance is effective for reporting
periods (including interim periods) beginning after December 15,
2016. Early adoption is permitted. The Company does not expect the
adoption of the amendments to have a material impact on the
Company’s financial position, results of operations, cash
flows or disclosures.
In
January 2016, the FASB issued ASU No. 2016-01, which makes limited
amendments to the guidance in U.S. GAAP on the classification and
measurement of financial instruments. The new standard
significantly revises an entity’s accounting related to (1)
the classification and measurement of investments in equity
securities and (2) the presentation of certain fair value changes
for financial liabilities measured at fair value. It also amends
certain disclosure requirements associated with the fair value of
financial instruments. ASU No. 2016-01 is effective for fiscal
years beginning after December 15, 2017, and interim periods within
those annual periods. The Company is in the process of evaluating
the amendments to determine if they have a material impact on the
Company’s financial position, results of operations, cash
flows or disclosures.
In
February 2016, the FASB issued new guidance, ASU No. 2016-02,
Leases (Topic 842). The main difference between current U.S. GAAP
and the new guidance is the recognition of lease liabilities based
on the present value of remaining lease payments and corresponding
lease assets for operating leases under current U.S. GAAP with
limited exception. Additional qualitative and quantitative
disclosures are also required by the new guidance. Topic 842 is
effective for annual reporting periods (including interim reporting
periods) beginning after December 15, 2018. Early adoption is
permitted. The Company is in the process of evaluating the
amendments to determine if they have a material impact on the
Company’s financial position, results of operations, cash
flows or disclosures.
In
August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows
(Topic 230) Classification of Certain Cash Receipts and Cash
Payments, which will make eight targeted changes to how cash
receipts and cash payments are presented and classified in the
Statement of Cash Flows. ASU 2016-15 will be effective on May 1,
2018, and will require adoption on a retrospective basis unless it
is impracticable to apply, in which case the Company would be
required to apply the amendments prospectively as of the earliest
date practicable. The Company is in the process of evaluating the
amendments to determine if they have a material impact on the
Company’s financial position, results of operations, cash
flows or disclosures.
In
August 2016, the FASB issued ASU 2017-01 that changes the
definition of a business to assist entities with evaluating when a
set of transferred assets and activities is a business. The
guidance requires an entity to evaluate if substantially all of the
fair value of the gross assets acquired is concentrated in a single
identifiable asset or a group of similar identifiable assets; if
so, the set of transferred assets and activities is not a business.
ASU 2017-01 also requires a business to include at least one
substantive process and narrows the definition of outputs by more
closely aligning it with how outputs are described in ASC 606.1.
ASU 2017-01 is effective for public business entities for fiscal
years beginning after December 15, 2017, and interim periods within
those years. Early adoption is permitted. The Company is in the
process of evaluating the amendments to determine if they have a
material impact on the Company’s financial position, results
of operations, cash flows or disclosures.
Revised Prior Quarter Amounts
While
preparing our November 30, 2016 year-end financial statements, we
identified and corrected a non-cash error related to the accounting
for the modification of performance-based stock options. In April
2016, our shareholders approved a two-year extension of the expiry
date of the performance-based options from September 2016 to
September 2018. We determined that this modification resulted in a
non-cash expense that should have been reflected in our 2016 second
quarter results. As stock-based compensation is a non-cash item,
this error did not impact net cash provided from operations in the
second quarter of fiscal 2016, nor did it have any impact on our
annual financial statements for the year ended November 30, 2016.
This error resulted in an understatement in the second quarter of
fiscal 2016 of stock-based compensation charged to R&D expense,
with a corresponding understatement of additional paid in capital,
of $1,177,782. We recorded the expense in the fourth quarter ended
November 30, 2016.
RESULTS OF OPERATIONS
Our
results of operations have fluctuated significantly from period to
period in the past and are likely to do so in the future. We
anticipate that our quarterly and annual results of operations will
be impacted for the foreseeable future by several factors,
including the timing of approvals to market of our product
candidates in various jurisdictions and any resulting licensing
revenue, milestone revenue, product sales, the number of
competitive products and the extent of any aggressive pricing
activity, wholesaler buying patterns, the timing and amount of
payments received pursuant to our current and future collaborations
with third parties, the existence of any first-to-file exclusivity
periods, and the progress and timing of expenditures related to our
research, development and commercialization efforts. Due to these
fluctuations, we presently believe that the period-to-period
comparisons of our operating results are not a reliable indication
of our future performance.
|
For the three months ended
|
|
|
For
the nine months ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
|
%
|
$
|
|
|
%
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
|
1,189,739
|
554,925
|
634,814
|
114%
|
4,426,617
|
1,677,906
|
2,748,711
|
164%
|
|
|
|
|
|
|
|
|
|
|
1,189,739
|
554,925
|
634,814
|
114%
|
4,426,617
|
1,677,906
|
2,748,711
|
164%
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
376,054
|
-
|
376,054
|
-
|
587,426
|
-
|
587,426
|
-
|
|
|
|
|
|
|
|
|
|
Gross
margin
|
813,685
|
554,925
|
258,760
|
47%
|
3,839,191
|
1,677,906
|
2,161,285
|
129%
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
2,298,804
|
1,633,150
|
665,654
|
41%
|
7,007,503
|
4,904,405
|
2,103,098
|
43%
|
Selling,
general and administrative
|
756,635
|
855,597
|
(98,962)
|
-12%
|
2,468,436
|
2,521,427
|
(52,991)
|
-2%
|
Depreciation
|
126,316
|
97,254
|
29,062
|
30%
|
331,102
|
283,380
|
47,722
|
17%
|
|
3,181,755
|
2,586,001
|
595,754
|
23%
|
9,807,041
|
7,709,212
|
2,097,829
|
27%
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
(2,368,070)
|
(2,031,076)
|
(336,994)
|
17%
|
(5,967,850)
|
(6,031,306)
|
63,456
|
-1%
|
|
|
|
|
|
|
|
|
|
Net
foreign exchange gain/(loss)
|
(90,875)
|
(26,163)
|
(64,712)
|
247%
|
(73,569)
|
(31,715)
|
(41,854)
|
132%
|
Interest
income
|
5
|
-
|
5
|
-
|
15,030
|
204
|
14,826
|
7268%
|
Interest
expense
|
(91,374)
|
(52,917)
|
(38,457)
|
73%
|
(320,115)
|
(167,456)
|
(152,659)
|
91%
|
Net
loss and comprehensive loss
|
(2,550,314)
|
(2,110,156)
|
(440,158)
|
21%
|
(6,346,504)
|
(6,230,273)
|
(116,231)
|
2%
|
Three months ended August 31, 2017 compared to the three months
ended August 31, 2016
Revenue
The
Company recorded revenues of $1,189,739 for the three month period
ended August 31, 2017, compared to $554,925 for the three months
ended August 31, 2016. A significant portion of our revenue is from
commercial sales of generic Focalin XR® (dexmethylphenidate
hydrochloride extended-release) capsules under the Par agreement.
The increase in revenues from the prior period quarter is due to
Par’s launch of additional strengths of generic Focalin
XR® capsules in the U.S. in 2017 and also reflects revenue
from the Company’s generic Seroquel XR® launched by
Mallinckrodt in June 2017. The Company’s revenues on the 25
and 35 mg strengths of generic Focalin XR® declined in July
2017 as the 6 month exclusivity period expired, however, revenue
from all strengths of the product are higher in the current period
than in the comparative three month period. Revenue for the third
quarter of fiscal 2017 also includes sales of the Company’s
generic Seroquel XR®
launched by Mallinckrodt in June 2017. As several generic
competitors entered the market in May 2017, Seroquel XR® sales
volumes did not reach the levels anticipated for the first three
months. Sales on a month over month basis have shown improvement as
generic Seroquel XR® begins to see good traction with key
accounts and large wholesalers and the Company expects revenues
from this product to increase going forward. Revenues under the Par
and Mallinckrodt agreements represent the commercial sales of the
generic products and may not be representative of future
sales.
Cost of goods sold
The
Company recorded cost of goods sold of $376,054 for the three
months ended August 31, 2017 versus $Nil for the three months ended
August 31, 2016. Cost of sales for the three months ended August
31, 2017, reflects the Company’s shipment of generic Seroquel
XR® to Mallinckrodt launched in June 2017. As the product was
launched in the current period, no cost of goods were recorded in
the prior year.
Research and Development
Expenditures
for R&D for the three months ended August 31, 2017 were higher
by $665,654 compared to the three months ended August 31, 2016. The
increase is primarily due to higher third party consulting fees
associated with our preparation for the FDA Advisory Committee
meeting in relation to our Oxycodone ER NDA filing.
In the
three months ended August 31, 2017, we recorded $12,951 as expense
for stock based compensation for R&D employees. In the three
months ended August 31, 2016, we recorded $144,326 as expenses for
stock-based compensation expense. Stock-based compensation expense
is a non-cash item.
After
adjusting for the stock-based compensation expenses discussed
above, expenditures for R&D for the three months ended August
31, 2017 were higher by $797,029 compared to the three months ended
August 31, 2016 due to an increase in third party R&D
expenditures.
Selling, General and
Administrative
Selling,
general and administrative expenses were $756,635 for the three
months ended August 31, 2017 in comparison to $855,597 for the
three months ended August 31, 2016, a decrease of $98,962. The
decrease is primarily due to the lower expenses related to a
decrease in wages, and marketing cost, partially offset by an
increase in occupancy cost, which are discussed in greater detail
below.
Expenditures
for wages and benefits for the three months ended August 31, 2017
were $308,572 in comparison to $429,805 in the three months ended
August 31, 2016, a decrease of $121,233, primarily due to higher
stock based compensation expense recorded in the three months ended
August 31, 2016. For the three months ended August 31, 2017, we
recorded $19,154 as an expense for stock-based compensation
compared to an expense of $188,032 for the three months ended
August 31, 2016.
Administrative
costs for the three months ended August 31, 2017 were $251,876 in
comparison to $250,875 in the three months ended August 31,
2016.
Marketing
costs for the three months ended August 31, 2017 were $160,957 in
comparison to $130,565 in the three months ended August 31, 2016.
The increase is attributable to the increase in travel expenditures
related to business development and investor relations
activities.
Occupancy
costs for the three months ended August 31, 2017 were $35,230 in
comparison to $44,352 for the three months ended August 31, 2016.
The decrease is primarily due to a decrease in expenditures in
maintenance related to our leased premises.
Depreciation
Depreciation
expenses for the three months ended August 31, 2017 were $126,316
in comparison to $97,254 in the three months ended August 31, 2016.
The increase is primarily due to a higher rate of investment in
production, laboratory and computer equipment during the most
recent quarter.
Net Foreign Exchange Loss
Foreign
exchange loss was $90,875 for the three months ended August 31,
2017 in comparison to a loss of $26,163 in the three months ended
August 31, 2016. The foreign exchange gain for the three months
ended August 31, 2017 was due to the weakening of the U.S. dollar
against the Canadian dollar during the three months ended August
31, 2017 as the exchange rates changed to $1.00 for C$1.2536 as at
August 31, 2017 from $1.00 for C$1.3500 as at May 31, 2017. The
foreign exchange loss for the three months ended August 31, 2016
was due to the modest weakening of the U.S. dollar against the
Canadian dollar during the three months ended August 31, 2015 as
the exchange rates changed to $1.00 for C$1.3116 as at August 31,
2016 from $1.00 for C$1.3110 as at May 31, 2016.
Interest Expense
Interest
expense for the three months ended August 31, 2017 was higher by
$38,457 compared with the prior period. This is primarily because
the interest expense paid on an unsecured convertible debenture in
the original principal amount of $1.5 million (the
“Debenture”), which accrues interest payable at 12%
annually and the related conversion option embedded derivative
accreted at an annual imputed interest of approximately 15.2% in
the third quarter of 2017 in comparison to the third quarter of
2016 when the Debenture imputed interest was approximately
4.2%.
Net Loss
The
Company recorded net loss for the three months ended August 31,
2017 of $2,550,314, or $0.08 per common share, compared with a net
loss of $2,110,156, or $0.07 per common share, for the three months
ended August 31, 2016. In the three months ended August 31, 2017,
the higher net loss is primarily attributed to an increase in
third-party R&D expenditures, partially offset by a higher
licensing revenue from commercial sales of generic Focalin XR®
and generic Seroquel XR® in the third quarter of 2017. During
the three months ended August 31, 2016, the loss was due to ongoing
R&D and selling, general and administrative expenses, including
an increase in options expense, partially offset by licensing
revenues from commercial sales of generic Focalin
XR®.
Nine Months Ended August 31, 2017 Compared to the Nine Month Ended
August 31, 2016
Revenue
The
Company recorded revenues of $4,426,617 for the nine months ended
August 31, 2017 versus $1,677,906 for the nine months ended August
31, 2016. Revenues consisted primarily of licensing revenues from
commercial sales of the 10,15, 20, 25, 30 and 35 mg of generic
Focalin XR® under the Par agreement. The increase in revenues
in the current year period is primarily due to Par’s January
2017 launch of the 25 and 35 mg strengths of generic Focalin
XR® capsules in the U.S and also reflects some revenue from
the Company’s generic Seroquel XR® launched by
Mallinckrodt in June 2017. The Company’s revenues on the 25
and 35 mg strengths of generic Focalin XR® showed a decline
commencing July 2017 when their 6 month exclusivity expired,
however, we believe the product continues to remain competitively
positioned in the market. The Company’s revenues on the 10
and 20 mg strengths of generic Focalin XR® in the nine months
ended August 31, 2017 are negligible due to their launch date being
late August 2017. Revenues under the Par and Mallinckrodt
agreements represents the commercial sales of the generic products
in those strengths and may not be representative of future
sales.
Cost of goods sold
The
Company recorded cost of goods sold of $587,426 for the nine months
ended August 31, 2017 versus $Nil for the nine months ended August
31, 2016. Cost of sales for the nine months ended August 31, 2017,
reflects the Company’s shipments of generic Seroquel XR®
to Mallinckrodt which are manufactured by the Company and supplied
to Mallinckrodt on a cost-plus basis.
Research and Development
Expenditures
for R&D for the nine months ended August 31, 2017 were higher
by $2,103,098 compared to the nine months ended August 31, 2016.
The increase is primarily due to higher stock option compensation
expense as a result of certain performance-based stock options
vesting upon FDA approval of quetiapine fumarate extended release
tablets in the 50, 150, 200, 300 and 400 mg strengths, as detailed
below. R&D expenses for the most recent quarter are also higher
due to higher third party consulting fees associated with our
preparation for the FDA Advisory Committee meeting in relation to
our Oxycodone ER NDA filing. As noted above under “Revised
Prior Quarter Amounts”, the R&D expenses for the nine
months ended August 31, 2016 should have been higher by $1,177,782
as a result of our shareholders approving an extension of the
expiry date of certain performance-based stock
options.
In the
nine months ended August 31, 2017, we recorded $1,614,977 of
expenses for stock-based compensation for R&D employees, of
which $1,577,772 was for expenses related to performance-based
stock options which vested on FDA approval for metformin
hydrochloride extended release tablets in February 2017 and FDA
approval of our quetiapine fumarate extended release tablets in May
2017. In the nine months ended August 31, 2016 we recorded $795,729
as expense for stock based compensation for R&D employees, of
which $620,632 was for expenses related to performance-based stock
options which vested on FDA approval of our generic Keppra XR®
in February 2016. Stock-based compensation expense is a non-cash
item.
After
adjusting for the stock-based compensation expenses discussed
above, expenditures for R&D for the nine months ended August
31, 2017 were higher by $1,283,850 compared to the nine months
ended August 31, 2016. The increase was primarily due to higher
compensation expense, costs related to preparing for the FDA
Advisory Committee meeting, as well as an increase in third party
R&D expenditures.
Selling, General and
Administrative
Selling,
general and administrative expenses were $2,468,436 for the nine
months ended August 31, 2017 in comparison to $2,521,427 for the
nine months ended August 31, 2016, a decrease of $52,991. The
decrease is due to lower wages and
benefits and administrative costs offset by
higher expenses
related to marketing cost and occupancy cost discussed in
greater detail below.
Expenditures
for wages and benefits for the nine months ended August 31, 2017
were $891,274 in comparison to $1,007,806 in the nine months ended
August 31, 2016. For the nine months ended August 31, 2017, we
recorded $61,997 as expense for stock-based compensation compared
to an expense of $237,487 for the nine months ended August 31,
2016. After adjusting for the stock-based compensation expenses,
expenditures for wages for the nine months ended August 31, 2017
were higher by $58,958 compared to the nine months ended August 31,
2016. The increase is attributable to higher compensation expense
for certain administrative employees.
Administrative
costs for the nine months ended August 31, 2017 were $1,084,435 in
comparison to $1,088,219 in the nine months ended August 31, 2016.
The decrease relates primarily to lower professional
fees.
Marketing
costs for the nine months ended August 31, 2017 were $390,012 in
comparison to $337,490 in the nine months ended August 31, 2016.
This increase is primarily the result of an increase in travel
expenditures related to business development and investor relations
activities.
Occupancy
costs for the nine months ended August 31, 2017 were $102,715 in
comparison to $87,912 for the nine months ended August 31, 2016.
The increase is due to the incremental cost of leasing an adjoining
facility in order to meet the Company’s anticipated growth
requirements.
Depreciation
Depreciation
expenses for the nine months ended August 31, 2017 were $331,102 in
comparison to $283,380 in the nine months ended August 31, 2016.
The increase is primarily due to the additional investment in
production, laboratory and computer equipment during the nine
months ended August 31, 2017.
Foreign Exchange Loss
Foreign
exchange loss was $73,569 for the nine months ended August 31, 2017
in comparison to a loss of $31,715 in the nine months ended August
31, 2016. The foreign exchange loss for the nine months ended
August 31, 2017 was due to the weakening of the U.S. dollar against
the Canadian dollar during the nine months ended August 31, 2017 as
the exchange rates changed to $1.00 for C$1.3500 as at August 31,
2017 from $1.00 for C$1.3429 as at November 30, 2016. The foreign
exchange loss for the nine months ended August 31, 2016 was due to
the weakening of the U.S. dollar against the Canadian dollar during
the nine months ended August 31, 2016 as the exchange rates changed
to $1.00 for C$1.3116 as at August 31, 2016 from $1.00 for C$1.3353
as at November 30, 2015.
During
the nine months ended August 31, 2017, the exchange rate averaged
$1.00 for C$1.3607 compared to $1.00 for C$1.3280 for the nine
months ended August 31, 2016.
Interest Income
Interest
income for the nine months ended August 31, 2017 was higher by
$14,826 in comparison to the prior period. For the nine months
ended August 31, 2017 interest was higher largely due to interest
received on input tax credit refunds under the Scientific Research
and Experimental Development (“SR&ED”)
program.
Interest Expense
Interest
expense for the nine months ended August 31, 2017 was higher by
$152,659 compared with the prior period. This is due to interest
expense paid in 2017 on the Debenture which accrues interest
payable at 12% annually and the related conversion option embedded
derivative accreted at an annual imputed interest of approximately
15.2%, in comparison to the first nine months of 2016 when the
Debenture imputed interest was approximately 4.2%.
Net Loss
The
Company recorded net loss for the nine months ended August 31, 2017
of $6,346,504 or $0.21 per common share, compared with a net loss
of $6,230,273 or $0.24 per common share for the nine months ended
August 31, 2016. In the nine months ended August 31, 2017, the net
loss was attributed to the ongoing R&D and selling, general and
administrative expenses, partially offset by licensing revenues
from commercial sales of generic Focalin XR® and to a lesser
extent, sales of generic Seroquel XR® shipped to Mallinckrodt.
The net loss in 2017 is similar to 2016 due to an increase in
performance based stock option expense and higher third party
R&D expenditures, offset by higher licensing revenues from
commercial sales of Focalin XR® and generic Seroquel XR®.
Revenue from commercial sales of Focalin XR® and generic
Seroquel XR® in the nine months ended August 31, 2017, was
$3,236,878 versus $1,122,981 in the prior period. This is primarily
due to the launch of additional strengths of Focalin XR® in
2017 as well as the launch of generic Seroquel XR®. In the
nine months ended August 31, 2016, the net loss is attributed to
lower licensing revenues from commercial sales of generic Focalin
XR® and, to a lesser extent, due to ongoing R&D and
selling, general and administrative expenses, including an increase
in options expense.
As
noted above under “Revised Prior Quarter Amounts”, this
error resulted in an understatement in the second quarter of fiscal
2016 of stock-based compensation charged to R&D expense,
resulting in the net loss for the three months ended August 31,
2016 being understated by $1,177,782 due to a non-cash
error.
SUMMARY OF QUARTERLY RESULTS
The
table below outlines selected financial data for the eight most
recent quarters. The quarterly results are unaudited and have been
prepared in accordance with U.S. GAAP, for interim financial
information.
|
|
|
|
|
|
|
|
|
Quarter Ended
|
$
|
$
|
$
|
$
|
August
31, 2017
|
1,189,739
|
(2,550,314)
|
(0.08)
|
(0.08)
|
May
31, 2017
|
2,001,512
|
(1,805,329)
|
(0.06)
|
(0.06)
|
February
28, 2017
|
1,235,366
|
(1,990,861)
|
(0.07)
|
(0.07)
|
November
30, 2016
|
569,096
|
(3,913,304)
|
(0.13)
|
(0.13)
|
August
31, 2016
|
554,925
|
(2,110,156)
|
(0.07)
|
(0.07)
|
May
31, 2016
|
556,044
|
(2,000,077)
|
(0.08)
|
(0.08)
|
February
29, 2016
|
566,937
|
(2,120,040)
|
(0.09)
|
(0.09)
|
November
30, 2015
|
845,103
|
(3,132,788)
|
(0.13)
|
(0.13)
|
(i)
Quarterly per share amounts may not sum due to
rounding
It is
important to note that historical patterns of revenue and
expenditures cannot be taken as an indication of future revenue and
expenditures. Net loss has been variable over the last eight
quarters, and has been impacted primarily by the commercial sales
of generic Focalin XR® capsules, the level of our R&D
spending, availability of funding and the vesting or modification
of performance-based stock options. The higher net loss in the
third quarter of 2017 is primarily due to lower licensing revenue
as a result of the expiration of exclusivity on the 25 and 35 mg
strengths of generic Focalin XR® resulting in higher than
normal wholesaler returns, along with higher expenses related to
the FDA Advisory Committee meeting in July 2017. The lower net loss
in the second quarter of 2017 is primarily attributed to higher
licensing revenues from commercial sales of generic Focalin
XR® in the 25 and 35 mg strengths complementing the 15 and 30
mg strengths of our generic Focalin XR® marketed by
Par., partially offset by an increase in performance-based options
expense and higher third party consulting fees. The lower net loss
in the first quarter of 2017 is primarily attributed to higher
licensing revenues from commercial sales of generic Focalin
XR® due to Par’s launch of the 25 and 35 mg strengths of
its generic Focalin XR® capsules in that quarter, partially
offset by an increase in performance-based options expense and
legal and other professional fees. The higher net loss in the
fourth quarter of 2016 is attributable the accrual of management
bonuses (there were no management bonuses paid in fiscal 2015) and
additional compensation costs related to vested performance-based
options as a result of the Company’s shareholders approving
an extension of the expiry date of the performance-based stock
options. As noted above under “Revised Prior Quarter
Amounts”, the latter item represents a non-cash error that
should have been expensed in the second quarter of 2016, resulting
in the fourth quarter net loss being overstated by $1,177,782 and
the second quarter net loss understated by the same amount. The net
losses in the first, second and third quarter of 2016 are fairly
consistent and attributable to lower licensing revenues from
commercial sales of generic Focalin XR® as the Company
continued to face stiff generic competition throughout fiscal 2016.
The higher net loss in the fourth quarter of 2015 is attributed to
ongoing R&D and selling, general and administrative expense,
including a significant increase in third party clinical
studies.
LIQUIDITY AND CAPITAL RESOURCES
|
For the three months ended
|
|
For the
nine months ended
|
|
|
|
|
|
|
|
|
|
|
|
|
Change
|
|
|
Change
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
|
%
|
$
|
$
|
|
%
|
Cash
flows used in operating activities
|
(1,354,713)
|
(3,863,237)
|
2,508,524
|
-65%
|
(4,027,439)
|
(6,988,449)
|
2,961,010
|
-42%
|
Cash
flows from financing activities
|
920,334
|
5,730,211
|
(4,809,877)
|
-84%
|
2,443,869
|
7,345,338
|
(4,901,469)
|
-67%
|
Cash
flows used in investing activities
|
(306,083)
|
(56,941)
|
(249,142)
|
438%
|
(1,825,698)
|
(128,724)
|
(1,696,974)
|
1318%
|
(Decrease)
increase in cash
|
(740,462)
|
1,810,033
|
(2,550,495)
|
-141%
|
(3,409,268)
|
228,165
|
(3,637,433)
|
-1594%
|
Cash,
beginning of period
|
1,475,618
|
173,328
|
1,302,290
|
751%
|
4,144,424
|
1,755,196
|
2,389,228
|
136%
|
Cash,
end of period
|
735,156
|
1,983,361
|
(1,248,205)
|
-63%
|
735,156
|
1,983,361
|
(1,248,205)
|
-63%
|
The
Company had cash of $735,156 as at August 31, 2017 compared to
$1,475,618 as at May 31, 2017. The decrease in cash during the
three months ended August 31, 2017 was mainly a result of our
ongoing expenditures in R&D and selling, general, and
administrative expenses, which includes increased consulting fees
incurred to prepare for the July 26, 2017 FDA Advisory Committee
meeting and an increase in purchases of plant and production
equipment to support our generic Seroquel XR® launch, which
were only partially offset by higher cash receipts from
commercialized sales of our generic Focalin XR® and cash
receipts provided from financing activities derived from common
share sales under the Company’s at-the-market offering
program. The increase in cash during the three months ended August
31, 2016 was mainly a result of an increase in cash flows provided
from financing activities due to the closing of an underwritten
public offering and common share sales under the Company’s
at-the-market offering program, partially offset by an increase in
cash flow used in operating activities related to R&D
activities and a decrease in purchases of production, laboratory
and computer equipment.
For the
three and nine months ended August 31, 2017, net cash flows used in
operating activities increased to $1,354,713 and $4,027,439 as
compared to net cash flows used in operating activities for the
three and nine months ended August 31, 2016 of $3,863,237 and
$6,988,449. The decrease was primarily due to a significant
reduction in accounts payable and accrued liabilities in the prior
period as well as a reduction of inventory and accounts receivable
levels in the current period.
R&D
costs, which are a significant portion of the cash flows used in
operating activities, related to continued internal R&D
programs are expensed as incurred. However, equipment and supplies
are capitalized and amortized over their useful lives if they have
alternative future uses. For the three months ended August 31, 2017
and the three months ended August 31, 2016, R&D expense was
$2,298,804, and $1,633,150, respectively. The increase was mainly
due to consulting fees associated with our preparation for the FDA
Advisory Committee meeting in relation to our Oxycodone ER NDA
filing.
For the
three and nine months ended August 31, 2017, net cash flows
provided from financing activities of $920,334 and $2,443,869
principally related to at-the-market issuances of common shares,
including and to the exercise of warrants, offset by payments on
the convertible debenture. For the three and nine months ended
August 31, 2016, net cash flows provided from financing activities
of $5,730,211 and $7,345,338 were principally related to the June
2016 underwritten public offering.
For the
three and nine months ended August 31, 2017, net cash flows used in
investing activities of $306,083 and $1,825,698 related primarily
to purchase of plant and production equipment required to support
our generic Seroquel XR® launch. For the three and nine months
ended August 31, 2016, net cash flows used in investing activities
of $56,941 and $128,724 related mainly to minor purchase of
production, laboratory and computer equipment.
All
non-cash items have been added back or deducted from the
consolidated unaudited interim statements of cash
flows.
With
the exception of the quarter ended February 28, 2014, the Company
has incurred losses from operations since inception. To date, the
Company has funded its R&D activities principally through the
issuance of securities, loans from related parties, funds from the
IPC Arrangement Agreement and funds received under commercial
license agreements. Since November 2013, research has also been
funded from revenues from sales of our generic Focalin XR®
capsules for the 15 and 30 mg strengths. With the launch of the 25
and 35 mg strengths by Par in January 2017, the launch of the 10
and 20 mg strengths in May 2017 along with the anticipated launch
of the 5 and 40 mg strengths in the near future, we expect revenues
of generic Focalin XR® to show improvement going forward. As
of August 31, 2017, the Company had a cash balance of $0.7 million.
As of October 10, 2017, our
cash balance was $0.3 million. We currently expect to
satisfy our operating cash requirements until December 2017 from
cash on hand and quarterly profit share payments from Par and
Mallinckrodt, supplemented by proceeds from equity issuances as
necessary. Should our marketing and distribution partner,
Mallinckrodt, continue to grow sales of our generic Seroquel
XR® at anticipated rates, then we expect to be cash flow
positive around the middle of fiscal 2018. Failing this, the
Company may need to obtain additional funding prior to that time as
we further the development of our product candidates and if we
accelerate our product commercialization activities. There can be
no assurance as to when or if Par will launch the remaining two
strengths of its generic Focalin XR® and, if launched, whether
they will be successfully commercialized, or if sales of generic
Seroquel XR® will continue to grow at expected levels. If
necessary, we expect to utilize the equity markets to bridge any
funding shortfall and to provide capital to continue to advance our
most promising product candidates. Our future operations are highly
dependent upon our ability to source additional capital to support
advancing our product pipeline through continued R&D activities
and to fund any significant expansion of our operations. Although
there can be no assurances, such capital may come from revenues
from the sales of our generic Focalin XR® capsules, from sales
of our generic Seroquel XR® tablets, from potential partnering
opportunities for approved products, or from proceeds of the
Company’s at-the-market offering program. Other potential
sources of capital may include payments from licensing agreements,
cost savings associated with managing operating expense levels,
other equity and/or debt financings, and/or new strategic
partnership agreements which fund some or all costs of product
development. Our ultimate success will depend on whether our
product candidates receive the approval of the FDA or Health Canada
and whether we are able to successfully market approved products.
We cannot be certain that we will be able to receive FDA or Health
Canada approval for any of our current or future product
candidates, that we will reach the level of sales and revenues
necessary to achieve and sustain profitability, or that we can
secure other capital sources on terms or in amounts sufficient to
meet our needs or at all. Our cash requirements for R&D during
any period depend on the number and extent of the R&D
activities we focus on. At present, we are working principally on
our Oxycodone ER 505(b)(2), and selected generic, product candidate
development projects. Our development of Oxycodone ER will require
significant expenditures, including costs to defend against the
Purdue litigation. For our RegabatinTM XR 505(b)(2)
product candidate, Phase III clinical trials can be capital
intensive, and will only be undertaken consistent with the
availability of funds and a prudent cash management strategy. We
anticipate some investment in fixed assets and equipment over the
next several months, the extent of which will depend on cash
availability.
Effective
September 28, 2017, the maturity date for the Debenture was
extended to October 1, 2018. The Company currently expects to repay
the current outstanding principal amount of $1,350,000 on or about
October 1, 2018, if the Company then has cash
available.
The
availability of equity or debt financing will be affected by, among
other things, the results of our R&D, our ability to obtain
regulatory approvals, our success in commercializing approved
products with our commercial partners and the market acceptance of
our products, the state of the capital markets generally, strategic
alliance agreements, and other relevant commercial considerations.
In addition, if we raise additional funds by issuing equity
securities, our then existing security holders will likely
experience dilution, and the incurring of indebtedness would result
in increased debt service obligations and could require us to agree
to operating and financial covenants that would restrict our
operations. In the event that we do not obtain sufficient
additional capital, it will raise substantial doubt about our
ability to continue as a going concern and realize our assets and
pay our liabilities as they become due. Our cash outflows are
expected to consist primarily of internal and external R&D,
legal and consulting expenditures to advance our product pipeline
and selling, general and administrative expenses to support our
commercialization efforts. Depending upon the results of our
R&D programs, the Purdue plaintiffs patent litigation case and
the availability of financial resources, we could decide to
accelerate, terminate, or reduce certain projects, or commence new
ones. Any failure on our part to successfully commercialize
approved products or raise additional funds on terms favorable to
us or at all, may require us to significantly change or curtail our
current or planned operations in order to conserve cash until such
time, if ever, that sufficient proceeds from operations are
generated, and could result in us not taking advantage of business
opportunities, in the termination or delay of clinical trials or us
not taking any necessary actions required by the FDA or Health
Canada for one or more of our product candidates, in curtailment of
our product development programs designed to identify new product
candidates, in the sale or assignment of rights to our
technologies, products or product candidates, and/or our inability
to file ANDAs, ANDSs or NDAs at all or in time to competitively
market our products or product candidates.
OUTSTANDING SHARE INFORMATION
As at
August 31, 2017, the Company has 31,023,152 common shares issued
and outstanding, which is an increase of 1,233,160 when compared to
November 30, 2016. The number of shares outstanding increased as a
result of exercises of warrants for 168,009 common shares, the sale
of 1,058,151 common shares under our at-the-market offering program
and exercises of options for 7,000 common shares. In November 2013,
we entered into an equity distribution agreement with Roth Capital
Partners, LLC (“Roth”), pursuant to which we originally
could from time to time sell up to 5,305,484 of our common shares
for up to an aggregate of $16.8 million (or such lesser amount as
may then be permitted under applicable exchange rules and
securities laws and regulations) through at-the-market issuances on
the NASDAQ or otherwise. During
the three and nine months ended August 31, 2017, an aggregate of
464,989 and 1,058,151 (three and nine months ended August 31, 2016
– 217,707 and 973,311) common shares were sold on NASDAQ for
gross proceeds of $1,047,143 and $2,495,615 (three and nine months
ended August 31, 2016 – $414,034 and $1,962,049), with net
proceeds to the Company of $1,017,378 and $2,423,621 (three and
nine months ended August 31, 2016 – $402,010 and $1,903,916),
respectively, under the at-the-market offering program. During the
three and nine months ended August 31, 2017, Roth received
aggregate compensation of $29,766 and $71,994 (three and nine
months ended August 31, 2016 – $12,024 and $58,133),
respectively, in connection with such sales. As a result of prior
sales of the Company’s common shares under the equity
distribution agreement, the Company may in the future offer and
sell its common shares with an aggregate purchase price of up to
$2,927,071 pursuant to the at-the-market program (or such lesser
amount as may then be permitted under applicable exchange rules and
securities laws and regulations). There can be no assurance that
any additional shares will be sold under the at-the-market program.
The number of options outstanding as of August 31, 2017 is
5,383,305, a decrease of 9,155 from November 30, 2016, due to the
7,000 options being exercised and the expiry of 2,155 options
during the nine months ended August 31, 2017. The warrants
outstanding as of August 31, 2017 represent 1,979,797 common shares
issuable upon the exercise of 5,140,464 outstanding warrants, a
decrease of 168,009 common shares (336,018 warrants) from November
30, 2016, due to the exercise of 336,018 warrants to purchase
168,009 common shares during the nine months ended August 31, 2017.
The number of deferred share units outstanding as of August 31,
2017 is 85,950, an increase of 9,207 from November 30, 2016. As of
October 10, 2017, the number of shares outstanding is
31,073,152.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT LIQUIDITY AND MARKET
RISK
Liquidity
risk is the risk that the Company will encounter difficulty raising
liquid funds to meet its commitments as they fall due. In meeting
its liquidity requirements, the Company closely monitors its
forecasted cash requirements with expected cash
drawdown.
We are
exposed to interest rate risk, which is affected by changes in the
general level of interest rates. Due to the fact that the
Company’s cash is deposited with major financial institutions
in an interest savings account, we do not believe that the results
of operations or cash flows would be affected to any significant
degree by a sudden change in market interest rates given their
relative short-term nature.
Trade
accounts receivable potentially subjects the Company to credit
risk. The Company provides an allowance for doubtful accounts equal
to the estimated losses expected to be incurred in the collection
of accounts receivable.
The
Company is also exposed to credit risk at period end from the
carrying value of its cash. The Company manages this risk by
maintaining bank accounts with a Canadian Chartered Bank. The
Company’s cash is not subject to any external
restrictions.
We are
exposed to changes in foreign exchange rates between the Canadian
and United States dollar which could affect the value of our cash.
The Company had no foreign currency hedges or other derivative
financial instruments as of August 31, 2017. The Company did not
enter into financial instruments for trading or speculative
purposes and does not currently utilize derivative financial
instruments.
The
Company has balances in Canadian dollars that give rise to exposure
to foreign exchange (“FX”) risk relating to the impact
of translating certain non-U.S. dollar balance sheet accounts as
these statements are presented in U.S. dollars. A strengthening
U.S. dollar will lead to a FX loss while a weakening U.S. dollar
will lead to a FX gain. For each Canadian dollar balance of $1.0
million, a +/- 10% movement in the Canadian currency held by the
Company versus the U.S. dollar would affect the Company’s
loss and other comprehensive loss by $0.1 million.
WORKING CAPITAL
Working
capital (defined as current assets minus current liabilities) has
decreased by approximately $3.9 million at August 31, 2017 from
November 30, 2016, mainly a result of a lower cash balance and an
increase in accounts payable, accrued liabilities and employee
costs payable, partially offset by an increase in inventory and
accounts receivable. We currently expect to satisfy our operating
cash requirements until November 2017 from cash on hand, quarterly
profit share payments from Par and Mallinckrodt, and, if necessary,
proceeds from our at-the-market offering program. We are actively
exploring partnership opportunities for both currently approved and
yet-to-be-approved products, as well as potential international
partnership opportunities for both existing and future products.
While the Company has some flexibility with its level of
expenditures, our future operations are highly dependent upon our
ability to source additional capital to support advancing our
product pipeline through continued R&D activities and to fund
any significant expansion of our operations. Our ultimate success
will depend on whether our product candidates receive the approval
of the FDA or Health Canada and whether we are able to successfully
market approved products. We cannot be certain that we will be able
to receive FDA or Health Canada approval for any of our current or
future product candidates, that we will reach the level of sales
and revenues necessary to achieve and sustain profitability, or
that we can secure other capital sources on terms or in amounts
sufficient to meet our needs or at all.
As a
R&D company, Intellipharmaceutics is eligible to receive
investment tax credits from various levels of government under the
SR&ED incentive programs. Depending on the financial condition
of our operating subsidiary Intellipharmaceutics Corp., R&D
expenses in any fiscal year could be claimed. Eligible R&D
expenses included salaries for employees involved in R&D, cost
of materials, equipment purchase as well as third party contract
services. This amount is not a reduction in income taxes but a form
of government refundable credits based on the level of R&D that
the Company carries out.
Effective
September 28, 2017, the maturity date for the Debenture was
extended to October 1, 2018. The Company currently expects to repay
the current outstanding principal amount of $1,350,000 on or about
October 1, 2018, if the Company then has cash
available.
CAPITAL EXPENDITURES
Total
capital expenditures in the three and nine months ended August 31,
2017 were $306,083 and $1,825,698 compared to $56,941 and $128,724
in the three and nine months ended August 31, 2016. Capital
expenditures in fiscal 2017 related primarily to the purchase of
plant and production equipment required to support our generic
Seroquel XR® launch. We anticipate continued investment in
fixed assets and equipment over the next several months due to the
acceleration of product commercialization activities, the extent of
which will depend on cash availability.
CONTRACTUAL OBLIGATIONS
In the
table below, we set forth our enforceable and legally binding
obligations and future commitments and obligations related to all
contracts. Some of the figures we include in this table are based
on management’s estimate and assumptions about these
obligations, including their duration, the possibility of renewal,
anticipated actions by third parties, and other factors. The
Company has entered into capital lease agreements for laboratory
equipment where the lease obligation will end in fiscal 2017.
Operating lease obligations relate to the lease of premises for the
combined properties, comprising the Company’s premises that
it currently operates from at 30 Worcester Road as well as the
adjoining property at 22 Worcester Road, which is indirectly owned
by the same landlord, which will expire in November 2020 with a 5
year renewal option. The Company also has an option to purchase the
combined properties after March 1, 2017 and up to November 30, 2020
based on a fair value purchase formula, but does not currently
expect to exercise this option in 2017.
|
|
Contractual Obligations
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
$
|
Third
parties
|
|
|
|
|
|
Accounts
payable
|
2,533,883
|
2,533,883
|
-
|
-
|
-
|
Accrued
liabilities
|
512,025
|
512,025
|
-
|
-
|
-
|
Operating
lease
|
622,206
|
191,448
|
430,758
|
-
|
-
|
Related
parties
|
|
|
-
|
|
|
Employee
costs payable
|
201,221
|
201,221
|
-
|
-
|
-
|
Convertible
debenture
|
1,363,750
|
1,363,750
|
-
|
-
|
-
|
Total
contractual obligations
|
5,233,085
|
4,802,327
|
430,758
|
-
|
-
|
CONTINGENCIES AND LITIGATION
From
time to time, we may be exposed to claims and legal actions in the
normal course of business. As at August 31, 2017, and continuing as
at October 10, 2017, we are not aware of any pending or threatened
material litigation claims against us, other than as described
below.
In
November 2016, we filed an NDA for our Oxycodone ER product
candidate (abuse-deterrent oxycodone hydrochloride extended release
tablets), relying on the 505(b)(2) regulatory pathway, which
allowed us to reference data from Purdue Pharma L.P.'s file for its
OxyContin® extended release oxycodone hydrochloride. The
Oxycodone ER application was accepted by the FDA for further review
in February 2017. We certified to the FDA that we believed that our
Oxycodone ER product candidate would not infringe any of sixteen
(16) patents associated with the branded product Oxycontin®
(the “Oxycontin® patents”) listed in the
FDA’s Approved Drug Products with Therapeutic Equivalence
Evaluations, commonly known as the Orange Book (the “Orange
Book”), or that such patents are invalid, and so notified
Purdue Pharma L.P. and the other owners of the subject patents
listed in the Orange Book of such certification. On April 7, 2017,
we received notice that Purdue Pharma L.P., Purdue Pharmaceuticals
L.P., The P.F. Laboratories, Inc., or collectively the Purdue
parties, Rhodes Technologies, and Grünenthal GmbH, or
collectively the Purdue litigation plaintiffs or plaintiffs, had
commenced patent infringement proceedings against us in the U.S.
District Court for the District of Delaware in respect of our NDA
filing for Oxycodone ER, alleging that Oxycodone ER infringes six
(6) out of the sixteen (16) patents. The complaint seeks injunctive
relief as well as attorneys' fees and costs and such other and
further relief as the Court may deem just and proper. An answer and
counterclaim have been filed.
As a
result of the commencement of these legal proceedings, the FDA is
stayed for 30 months from granting final approval to our Oxycodone
ER product candidate. That time period commenced on February 24,
2017, when the plaintiffs received notice of our certification
concerning the patents, and will expire on August 24, 2019, unless
the stay is earlier terminated by a final declaration of the courts
that the patents are invalid, or are not infringed, or the matter
is otherwise settled among the parties. A trial date for the Purdue
litigation has been set for October 22, 2018. We are confident that
we do not infringe the subject patents, and will vigorously defend
against these claims.
In July
2017, the Company announced a purported class action complaint was
filed in the S.D.N.Y Court (No. 1:17-cv-05761) by Shawn Shanawaz on
behalf of himself and all others similarly situated against the
Company and two of its executive officers. The complaint alleges
that the Company and the executive officers violated Sections 10(b)
and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5
promulgated thereunder by making allegedly false and misleading
statements or failing to disclose certain information regarding the
Company’s NDA for Oxycodone ER abuse-deterrent oxycodone
hydrochloride extended release tablets. The complaint seeks, among
other remedies, unspecified damages, attorneys’ fees and
other costs, equitable and/or injunctive relief, and such other
relief as the court may find just and proper. Subsequently in
August 2017, two additional substantially similar
(in substance and
relief sought) actions were filed by Guy
Braverman (No. 1:17-cv-06045) and David Ducharme (No.
1:17-cv-06621) in the S.D.N.Y. Court. We anticipate that all three
actions will be consolidated into one complaint. The Company and
its management intend to vigorously defend against the allegations
set forth in the complaints.
RELATED PARTY TRANSACTIONS
In
January 2013, the Company completed the private placement financing
of an unsecured Debenture in the principal amount of $1.5 million.
The Debenture bears interest at a rate of 12% per annum, payable
monthly, is pre-payable at any time at the option of the Company,
and is convertible at any time into common shares at a conversion
price of $3.00 per common share at the option of the holder. Drs.
Isa and Amina Odidi, our principal stockholders, directors and
executive officers provided us with an original $1.5 million of the
proceeds for the Debenture. In December 2016, a principal repayment
of $150,000 was made on the Debenture. Effective September 28,
2017, the maturity date for the Debenture was extended to October
1, 2018. The Company currently expects to repay the current
outstanding principal amount of $1,350,000 on or about October 1,
2018, if the Company then has cash available.
DISCLOSURE CONTROLS AND PROCEDURES
Under
the supervision and with the participation of our management,
including the Chief Executive Officer and the Chief Financial
Officer, we have evaluated the effectiveness of our disclosure
controls and procedures as of August 31, 2017. Disclosure controls
and procedures are designed to ensure that the information required
to be disclosed by the Company in the reports it files or submits
under securities legislation is recorded, processed, summarized and
reported on a timely basis and that such information is accumulated
and communicated to management, including the Company’s Chief
Executive Officer and Chief Financial Officer, as appropriate, to
allow required disclosures to be made in a timely fashion. Based on
that evaluation, management has concluded that these disclosure
controls and procedures were effective as of August 31,
2017.
INTERNAL CONTROL OVER FINANCIAL REPORTING
The
management of our Company is responsible for establishing and
maintaining adequate internal control over financial reporting for
the Company. Internal control over financial reporting is a process
designed to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements
in accordance with generally accepted accounting principles and
includes those policies and procedures that (1) pertain to the
maintenance of records that, in reasonable detail, accurately and
fairly reflect the transactions and dispositions of the
Company’s assets, (2) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted
accounting principles, and that the Company’s receipts and
expenditures are being made only in accordance with authorizations
of the Company’s management and directors, and (3) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the
Company’s assets that could have a material effect on the
financial statements.
Management
assessed the effectiveness of the Company’s internal control
over financial reporting using the 1992 Internal Control-Integrated
Framework developed by the Committee of Sponsoring Organizations of
the Treadway Commission ("COSO").
Based
on this assessment, management concluded that the Company’s
internal control over financial reporting was effective as of
August 31, 2017. Management has not identified any material
weaknesses or changes in the Company’s internal control over
financial reporting as of August 31, 2017 that occurred during the
nine months ended August 31, 2017 that has materially affected, or
is reasonably likely to materially affect, the Company’s
internal control over financial reporting.
A third
party consultant was engaged to assist management in conducting a
gap assessment relative to the Company’s plans to implement
the COSO 2013 Internal Control – Integrated Framework. In the
second quarter of 2017, we initiated the transition from the COSO
1992 Internal Control - Integrated Framework to the COSO
2013 Internal Control - Integrated Framework. Progress thus
far has centered on strengthening our risk assessment process as
well as our information technology policies and related
documentation. We expect this transition to continue for the
remainder of fiscal 2017 and into next fiscal year. Although we do
not expect to experience significant changes in internal control
over financial reporting as a result of our transition, we may
identify significant deficiencies or material weaknesses and incur
additional costs in the future as a result of our
transition.
Changes in Internal Control over Financial Reporting
During
the third quarter of 2017, there were no changes made to the
Company’s internal control over financial reporting that have
materially affected, or are reasonably likely to materially affect,
the Company’s internal control over financial reporting, and
specifically, there were no changes in accounting functions, board
or related committees and charters, or auditors; no functions,
controls or financial reporting processes of any constituent
entities were adopted as the Company’s functions, controls
and financial processes; and no other significant business
processes were implemented.
OFF-BALANCE SHEET ARRANGEMENTS
The
Company, as part of its ongoing business, does not participate in
transactions that generate relationships with unconsolidated
entities or financial partnerships, such as entities often referred
to as structured finance or special purpose entities
(“SPE”), which would have been established for the
purpose of facilitating off-balance sheet arrangements or other
contractually narrow or limited purposes. As of August 31, 2017,
the Company was not involved in any material unconsolidated SPE
transactions.
RISKS AND UNCERTAINTIES
We are
a R&D company that received final FDA approval of our once
daily generic Focalin XR® (dexmethylphenidate hydrochloride
extended-release) capsules for the 15 and 30 mg strengths in
November 2013. We depend significantly on the actions of our
development partner Par in the prosecution, regulatory approval and
commercialization of our generic Focalin XR® capsules and on
their timely payment to us of the contracted quarterly payments as
they come due. Our near term ability to generate significant
revenue will depend upon successful commercialization of our
products in the U.S., where the branded Focalin XR® product is
in the market. Although we have several other products in our
pipeline, and received final approval from the FDA for our generic
Keppra XR® (levetiracetam extended-release tablets) for the
500 and 750 mg strengths, final approval from the FDA for our
generic Glucophage XR® (metformin hydrochloride extended
release tablets) in the 500 and 750 mg strengths and of our generic
Seroquel XR® which is partnered with Mallinckrodt, the
majority of the products in our pipeline are at earlier stages of
development. We will be exploring licensing and commercial
alternatives for our generic Keppra XR® and generic Glucophage
XR® product strengths that have been approved by the FDA.
Because of these characteristics, the Company is subject to certain
risks and uncertainties, or risk factors. The Company cannot
predict or identify all such risk factors nor can it predict the
impact, if any, of the risk factors on its business operations or
the extent to which a factor, event or any such combination may
materially change future results of financial position from those
reported or projected in any forward looking statements.
Accordingly, the Company cautions the reader not to rely on
reported financial information and forward looking statements to
predict actual future results. This report and the accompanying
financial information should be read in conjunction with this
statement concerning risks and uncertainties. Some of the risks,
uncertainties and events that may affect the Company, its business,
operations and results of operations are given in this section.
However, the factors and uncertainties are not limited to those
stated.
We
believe that the revenues derived from our generic Focalin XR®
capsules are subject to wholesaler buying patterns, increased
generic competition negatively impacting price, margins and market
share consistent with industry post-exclusivity experience and, to
a lesser extent, seasonality (as these products are indicated for
conditions including attention deficit hyperactivity disorder which
we expect may see increases in prescription rates during the school
term and declines in prescription rates during the summer months).
Accordingly, these factors may cause our operating results to
fluctuate.
Since
we commenced operations, we have incurred accumulated losses
through August 31, 2017. We had an accumulated deficit of
$69,362,523 as of August 31, 2017 and have incurred additional
losses since such date. As we engage in the development of products
in our pipeline, we will continue to incur further losses. There
can be no assurance that we will ever be able to achieve or sustain
profitability or positive cash flow. Our ultimate success will
depend on whether our product candidates receive the approval of
the FDA or Health Canada and whether we are able to successfully
market approved products. We cannot be certain that we will be able
to receive FDA or Health Canada approval for any of our current or
future product candidates, that we will reach the level of sales
and revenues necessary to achieve and sustain profitability, or
that we can secure other capital sources on terms or in amounts
sufficient to meet our needs or at all.
Our
business requires substantial capital investment in order to
conduct the R&D, clinical and regulatory activities necessary
and to defend against patent litigation claims in order to bring
our products to market and to establish commercial manufacturing,
marketing and sales capabilities. In the event that we do not
obtain sufficient additional capital, it will raise substantial
doubt about our ability to continue as a going concern and realize
our assets and pay our liabilities as they become due.
Our
cash outflows are expected to consist primarily of internal and
external R&D, legal and consulting expenditures to advance our
product pipeline and selling, general and administrative expenses
to support our commercialization efforts. Depending upon the
results of our R&D programs, the impact of the Purdue
litigation and the availability of financial resources, we could
decide to accelerate, terminate, or reduce certain projects, or
commence new ones. Any failure on our part to successfully
commercialize approved products or raise additional funds on terms
favorable to us, or at all, may require us to significantly change
or curtail our current or planned operations in order to conserve
cash until such time, if ever, that sufficient proceeds from
operations are generated, and could result in us not taking
advantage of business opportunities, in the termination or delay of
clinical trials or us not taking any necessary actions required by
the FDA or Health Canada for one or more of our product candidates,
in curtailment of our product development programs designed to
identify new product candidates, in the sale or assignment of
rights to our technologies, products or product candidates, and/or
our inability to file ANDAs, ANDSs or NDAs at all or in time to
competitively market our products or product
candidates.
We set
goals regarding the expected timing of meeting certain corporate
objectives, such as the commencement and completion of clinical
trials, anticipated regulatory approval and product launch dates.
From time to time, we may make certain public statements regarding
these goals. The actual timing of these events can vary
dramatically due to, among other things, insufficient funding,
delays or failures in our clinical trials or bioequivalence
studies, the uncertainties inherent in the regulatory approval
process, such as failure to secure requested product labeling
approvals, requests for additional information, delays in achieving
manufacturing or marketing arrangements necessary to commercialize
our products and failure by our collaborators, marketing and
distribution partners, suppliers and other third parties to fulfill
contractual obligations. In addition, the possibility of a patent
infringement suit regarding one or more of our product candidates
could delay final FDA approval of such candidates and materially
adversely affect our ability to market our products. Even if we are
found not to infringe any patent claims or the claims are found
invalid or unenforceable, defending any such infringement claims
could be expensive and time-consuming and could distract management
from their normal responsibilities. If we fail to achieve one or
more of our planned goals, the price of our common shares could
decline.
Further risks and uncertainties affecting us can be found elsewhere
in this document, in our latest Annual Information Form, our latest
Form F-3 (including any documents forming a part thereof or
incorporated by reference therein), and our latest Form 20-F, and
other public documents filed on SEDAR and EDGAR.
ADDITIONAL INFORMATION
Additional
information relating to the Company, including the Company’s
latest Annual Information Form, our latest Form F-3 (including any
documents forming a part thereof or incorporated by reference
therein), and latest Form 20-F, can be located under the
Company’s profile on the SEDAR website at www.sedar.com and
on the EDGAR section of the SEC’s website at www.sec.gov.