TORONTO, ON / ACCESSWIRE / February 22, 2019 / Intellipharmaceutics International Inc. (NASDAQ: IPCI, TSX: IPCI) (”Intellipharmaceutics” or the ”Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today reported the results of operations for the year ended November 30, 2018. All dollar amounts referenced herein are in United States dollars unless otherwise noted.
Fiscal 2018 highlights
”We believe our fiscal 2018 results are a positive reflection of our focus on our Oxycodone ER, Oxycodone IR and other 505(b)(2) development programs, despite financially challenging circumstances” said Dr. Isa Odidi, CEO of Intellipharmaceutics. ”We continue to move forward with our existing development programs, manufacturing and commercial efforts while also considering new product candidates and markets.”
Corporate Developments
Results of Operations
The Company recorded net loss for the year ended November 30, 2018 of $13.8 million or $2.89 per common share, compared with a net loss of $8.9 million or $2.86 per common share for the year ended November 30, 2017. In the year ended November 30, 2018, the higher net loss is attributed to the lower licensing revenues from commercial sales of generic Focalin XR® and lower licensing revenues from Quetiapine ER our generic Seroquel XR® (quetiapine fumarate extended-release) combined with increased third party R&D expenses primarily related to clinical trials for the Company’s Oxycodone ER product, legal and other administrative expenses. In the year ended November 30, 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 Company recorded revenues of $1.7 million for the year ended November 30, 2018 versus $5.5 million for the year ended November 30, 2017. Such revenues consisted primarily of licensing revenues from commercial sales of the 15, 25, 30 and 35 mg strengths of our generic Focalin XR® under the Par agreement. The decrease in revenues in the year ended November 30, 2018 compared to year ended November 30, 2017 is primarily due to considerably lower profit share payments from sales of generic Focalin XR® capsules in the U.S. Beginning in early 2018, we began to see significant impact from aggressive pricing by competitors, resulting in a marked increase in gross-to-net deductions such as wholesaler rebates, chargebacks and pricing adjustments. While the gross-to-net deductions fluctuate on a quarter over quarter basis, profit share payments for the last several quarters have shown decline over the same period in the prior year. Revenues from generic Seroquel XR® are still well below levels expected at the launch of the product in 2017, primarily due to the Company’s commercial partner entering the market later than planned. Several initiatives to gain market share have shown some improved returns, however, it is expected to take some time to determine if the product can achieve meaningful market penetration. Management is continuing to evaluate strategic options to improve returns from this product.
Expenditures for R&D for the year ended November 30, 2018 were higher by $1.6 million compared to the year ended November 30, 2017. The increase is primarily due to higher third party consulting fees and higher patent litigation expenses. After adjusting for the stock-based compensation expenses, expenditures for R&D for the year ended November 30, 2018 were higher by $2.3 million compared to the year ended November 30, 2017. The increase was primarily due to an increase in third party R&D expenditures as a result of clinical trials for Oxycodone ER and higher patent litigation expenses.
Selling, general and administrative expenses were $3.5 million for the year ended November 30, 2018 in comparison to $3.3 million for the year ended November 30, 2017, an increase of $0.2. The increase is due to higher expenses related to administrative costs, partially offset by a decrease in wages and marketing cost.
The Company had cash of $6.6 million as at November 30, 2018 compared to $1.9 million as at November 30, 2017. The increase in cash was mainly due to the cash receipts provided from financing activities derived from the Company’s two registered direct offering in March 2018, the 2018 Debenture financing in September 2018 and an underwritten public offering in October 2018, offset by ongoing expenditures in R&D and selling, general and administrative expenses.
As of February 22, 2019, our cash balance was $3.0 million. We currently expect to satisfy our operating cash requirements until May 2019 from cash on hand and quarterly profit share payments from Par and Mallinckrodt. The Company will need to obtain additional funding as we further the development of our product candidates. Potential sources of capital may include payments from licensing agreements, cost savings associated with managing operating expense levels, equity and/or debt financings and/or new strategic partnership agreements which fund some or all costs of product development. We intend 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. 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.
There can be no assurance that our products 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 candidate, that the FDA will approve any of our requested abuse-deterrence label claims or that the FDA will ultimately approve the NDA for the sale of our Oxycodone ER product candidate in the U.S. market, that we will be successful in submitting any additional ANDAs or NDAs with the FDA or 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, that any of our products or product candidates will receive regulatory approval for sale in other jurisdictions (including the Philippines, Malaysia and Vietnam), that our desvenlafaxine extended-release will receive final FDA approval, or that any of our products will ever be successfully commercialized and produce significant revenue for us. Furthermore, there can be no assurances regarding our ability to comply with the Nasdaq continued listing standards acceptable to a Nasdaq Panel, as described below. Moreover, there can be no assurance that any of our provisional patent applications will successfully mature into patents, or that any cannabidiol-based product candidates we develop will ever be successfully commercialized or produce significant revenue for us.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. Intellipharmaceutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development. The Company has ANDA and NDA 505(b)(2) drug product candidates in its development pipeline. These include the Company’s abuse-deterrent oxycodone hydrochloride extended release formulation (”Oxycodone ER”) based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules).
Cautionary Statement Regarding Forward-Looking Information
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 expectations regarding our plans, goals and milestones, status of
developments or expenditures relating to our business, plans to fund our
current activities, and 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 “appear”, “unlikely”, “target”, “may”,
“will”, “should”, “expects”, “plans”,
“plans to”, “anticipates”, “believes”,
“estimates”, “predicts”, “confident”,
“prospects”, “potential”, “continue”,
“intends”, “look forward”, “could”, “would”,
“projected”, “goals” ,”set to”, “seeking” 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 comply with the Nasdaq
and TSX continued listing standards and our ability to develop and implement a plan
of compliance with the Nasdaq continued listing standards acceptable to a
Nasdaq Panel, 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, 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 rights
for our drug delivery technologies, products and product candidates, recent and
future legal developments in the United States and elsewhere that could make it
more difficult and costly for us to obtain regulatory approvals for our product
candidates and negatively affect the prices we may charge, increased public
awareness and government scrutiny of the problems associated with the potential
for abuse of opioid based medications, pursuing growth through international
operations could strain our resources, our limited manufacturing, sales,
marketing or distribution capability and our reliance on third parties for
such, 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, seasonal fluctuations in
the number of prescriptions written for our generic Focalin XR® capsules and
our generic Seroquel XR® tablets which may produce substantial fluctuations in
revenue, the timing and amount of insurance reimbursement regarding our
products, changes in laws and regulations affecting the conditions required by
the 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, the effect of recently-enacted changes in U.S. federal
income tax laws, including but not limited to, limitations on the deductibility
of business interest, limitations on the use of net operating losses and
application of the base erosion minimum tax, on our U.S. corporate income tax
burden, 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 ANDAs and NDAs, challenges in securing final FDA approval for our product candidates,
including our oxycodone hydrochloride extended release tablets product
candidate, 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 and targeting common forms of abuse (oral,
intra-nasal and intravenous), 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 the “Risk Factors” section of our
latest annual information form, our latest Form 20-F, and our latest Form F-1
and F-3 (including any documents forming a part thereof or incorporated by
reference therein), as amended, as well as 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 and 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.
Trademarks used herein are the property of their respective holders.
Unless the context otherwise requires, all references (i) to ”we,” ”us,” ”our,” ”Intellipharmaceutics,” and the ”Company” refer to Intellipharmaceutics International Inc. and its subsidiaries and (ii) in this document to share amounts, per share data, share prices, exercise prices and conversion rates have been adjusted to reflect the effect of the 1-for-10 reverse split which became effective on each of Nasdaq and TSX at the open of market on September 14, 2018.
Nothing contained in this document should 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.
The audited consolidated financial statements, accompanying notes to the audited consolidated financial statements, and Management Discussion and Analysis for the year ended November 30, 2018 will be accessible on Intellipharmaceutics’ website at www.intellipharmaceutics.com and will be available on SEDAR and EDGAR.
Summary financial tables are provided below.
Intellipharmaceutics International Inc.
|
||||||||
Consolidated balance sheets
|
||||||||
As at November 30, 2018 and 2017
|
||||||||
(Stated in U.S. dollars)
|
||||||||
2018
|
2017
|
|||||||
$
|
$
|
|||||||
Assets
|
||||||||
Current
|
||||||||
Cash
|
6,641,877 | 1,897,061 | ||||||
Accounts receivable, net
|
239,063 | 689,619 | ||||||
Investment tax credits
|
998,849 | 636,489 | ||||||
Prepaid expenses, sundry and other assets
|
586,794 | 225,092 | ||||||
Inventory
|
251,651 | 115,667 | ||||||
8,718,234 | 3,563,928 | |||||||
Deferred offering costs
|
– | 565,302 | ||||||
Property and equipment, net
|
2,755,993 | 3,267,551 | ||||||
11,474,227 | 7,396,781 | |||||||
Liabilities
|
||||||||
Current
|
||||||||
Accounts payable
|
2,643,437 | 2,060,084 | ||||||
Accrued liabilities
|
353,147 | 782,369 | ||||||
Employee costs payable
|
222,478 | 214,980 | ||||||
Convertible debentures
|
1,790,358 | 1,290,465 | ||||||
Deferred revenue
|
300,000 | 300,000 | ||||||
5,309,420 | 4,647,898 | |||||||
Deferred revenue
|
2,062,500 | 2,362,500 | ||||||
7,371,920 | 7,010,398 | |||||||
Shareholders’ equity
|
||||||||
Capital stock
|
||||||||
Authorized
|
||||||||
Unlimited common shares without par value
|
||||||||
Unlimited preference shares
|
||||||||
Issued and outstanding
|
||||||||
18,252,243 common shares
|
44,327,952 | 35,290,034 | ||||||
(November 30, 2017 – 3,470,451)
|
||||||||
Additional paid-in capital
|
45,110,873 | 36,685,387 | ||||||
Accumulated other comprehensive income
|
284,421 | 284,421 | ||||||
Accumulated deficit
|
(85,620,939 | ) | (71,873,459 | ) | ||||
4,102,307 | 386,383 | |||||||
Contingencies
|
||||||||
11,474,227 | 7,396,781 |
Intellipharmaceutics International Inc.
|
||||||||||||
Consolidated statements of operations and comprehensive loss
|
||||||||||||
for the years ended November 30, 2018, 2017 and 2016
|
||||||||||||
(Stated in U.S. dollars)
|
||||||||||||
2018
|
2017
|
2016
|
||||||||||
$
|
$
|
$
|
||||||||||
Revenues
|
||||||||||||
Licensing
|
1,370,607 | 5,025,350 | 2,209,502 | |||||||||
Up-front fees
|
342,124 | 479,102 | 37,500 | |||||||||
1,712,731 | 5,504,452 | 2,247,002 | ||||||||||
Cost of goods sold
|
124,870 | 704,006 | – | |||||||||
Gross Margin
|
1,587,861 | 4,800,446 | 2,247,002 | |||||||||
Expenses
|
||||||||||||
Research and development
|
10,827,293 | 9,271,353 | 8,166,736 | |||||||||
Selling, general and administrative
|
3,476,450 | 3,287,914 | 3,546,132 | |||||||||
Depreciation
|
610,384 | 506,961 | 385,210 | |||||||||
14,914,127 | 13,066,228 | 12,098,078 | ||||||||||
Loss from operations
|
(13,326,266 | ) | (8,265,782 | ) | (9,851,076 | ) | ||||||
Net foreign exchange (loss) gain
|
8,592 | (80,093 | ) | (22,470 | ) | |||||||
Interest income
|
227 | 15,037 | 207 | |||||||||
Interest expense
|
(255,231 | ) | (389,239 | ) | (270,238 | ) | ||||||
Financing cost
|
(174,802 | ) | (137,363 | ) | – | |||||||
Net loss and comprehensive loss
|
(13,747,480 | ) | (8,857,440 | ) | (10,143,577 | ) | ||||||
Loss per common share, basic and diluted
|
(2.89 | ) | (2.86 | ) | (3.80 | ) | ||||||
Weighted average number of common
|
||||||||||||
shares outstanding, basic and diluted
|
4,762,274 | 3,101,448 | 2,669,958 |
Intellipharmaceutics International Inc.
|
||||||||||||
Consolidated statements of cash flows
|
||||||||||||
for the years ended November 30, 2018, 2017 and 2016
|
||||||||||||
(Stated in U.S. dollars)
|
||||||||||||
2018
|
2017
|
2016
|
||||||||||
$
|
$
|
$
|
||||||||||
Net loss
|
(13,747,480 | ) | (8,857,440 | ) | (10,143,577 | ) | ||||||
Items not affecting cash
|
||||||||||||
Depreciation
|
612,736 | 520,838 | 385,210 | |||||||||
Stock-based compensation
|
927,686 | 1,749,999 | 2,261,444 | |||||||||
Deferred share units
|
7,565 | 30,355 | 31,628 | |||||||||
Accreted interest
|
66,560 | 219,497 | 79,245 | |||||||||
Financing cost
|
174,802 | 137,363 | – | |||||||||
Provision for doubtful debts
|
– | 66,849 | – | |||||||||
Unrealized foreign exchange loss (gain)
|
52,613 | 56,998 | 22,916 | |||||||||
Change in non-cash operating assets & liabilities
|
||||||||||||
Accounts receivable
|
450,556 | (283,994 | ) | 6,200 | ||||||||
Investment tax credits
|
(362,360 | ) | 44,647 | (223,115 | ) | |||||||
Prepaid expenses, sundry and other assets
|
(361,702 | ) | 175,550 | (171,417 | ) | |||||||
Inventory
|
(135,984 | ) | (115,667 | ) | – | |||||||
Accounts payable, accrued liabilities and employee costs payable
|
106,048 | 599,220 | (1,466,019 | ) | ||||||||
Deferred revenue
|
(300,000 | ) | (450,000 | ) | 2,962,500 | |||||||
Cash flows used in operating activities
|
(12,508,960 | ) | (6,105,785 | ) | (6,254,985 | ) | ||||||
Financing activities
|
||||||||||||
Repayment of 2013 Debenture
|
– | (150,000 | ) | – | ||||||||
2018 Debenture financing
|
500,000 | – | – | |||||||||
Repayment of capital lease obligations
|
– | (14,829 | ) | (21,291 | ) | |||||||
Issuance of shares on exercise of stock options
|
– | 1,742 | 52,868 | |||||||||
Issuance of common shares on at-the-market financing, gross
|
– | 2,541,640 | 3,469,449 | |||||||||
Proceeds from issuance of shares and warrants
|
19,644,906 | 4,000,000 | 5,939,967 | |||||||||
Proceeds from issuance of shares on exercise of warrants
|
111,253 | 324,258 | 700,653 | |||||||||
Proceeds from shares to be issued from exercise of Pre-Funded Warrants
|
10,300 | – | – | |||||||||
Offering costs
|
(2,911,505 | ) | (1,020,643 | ) | (982,023 | ) | ||||||
Cash flows provided from financing activities
|
17,354,954 | 5,682,168 | 9,159,623 | |||||||||
Investing activity
|
||||||||||||
Purchase of property and equipment
|
(101,178 | ) | (1,823,746 | ) | (515,410 | ) | ||||||
Cash flows used in investing activities
|
(101,178 | ) | (1,823,746 | ) | (515,410 | ) | ||||||
Increase (decrease) in cash
|
4,744,816 | (2,247,363 | ) | 2,389,228 | ||||||||
Cash, beginning of year
|
1,897,061 | 4,144,424 | 1,755,196 | |||||||||
Cash, end of year
|
6,641,877 | 1,897,061 | 4,144,424 | |||||||||
Supplemental cash flow information
|
||||||||||||
Interest paid
|
209,675 | 123,204 | 165,585 | |||||||||
Taxes paid
|
– | – | – |
CONTACT INFORMATION
Company Contact:
Intellipharmaceutics International Inc.
Greg Powell
Chief Financial Officer
416.798.3001 ext. 106
investors@intellipharmaceutics.com
Investor Contact:
ProActive Capital
Kirin Smith
646.863.6519
ksmith@pcgadvisors.com
SOURCE: Intellipharmaceutics International Inc.
View source version on accesswire.com:
https://www.accesswire.com/536335/Intellipharmaceutics-Announces-Fiscal-Year-2018-Results
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