VANCOUVER, November 29, 2017 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today reported financial results for the three months ended September 30, 2017 and associated Company developments. Unless otherwise noted, all figures are in Canadian currency.
Corporate and Commercial Highlights
The Company continues to grow revenues from its Canadian commercial arm through the on-going promotion of Vistitan™ and Tacrolimus IR. Vistitan™ (bimatoprost 0.03%) is a treatment for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension, a market estimated to be over $185 million in 2015 in Canada. Since its launch, and with the support of Aequus’ promotional efforts, Vistitan™ has been successfully listed among 90% of private payor groups as well as a benefit under key provincial formularies, including the Ontario Drug Benefit Plan, Alberta Health and Manitoba Health. Tacrolimus IR is the first to market, and currently the only available generic version of tacrolimus immediate release in Canada, a product used for the treatment and prevention of acute rejection following organ transplantation. Tacrolimus IR, promoted by Aequus, continues to grow as it gains market share from branded tacrolimus alternatives. Aequus splits revenues of these two products with its partner based on a tiered royalty structure.
Revenue for the current quarter was $291,154, a 56% increase compared to revenues of $186,586 in the immediately preceding second quarter of 2017. Aequus recorded a decrease of 13% in net loss compared to the same quarter in 2016, primarily due to continued efforts to optimize general and administration spending as well as sales force efficiencies achieved throughout the reported period.
Aequus plans to launch an additional product in ophthalmology that is currently under review by Health Canada, through a previously announced partnership with Santen. This product is expected to enter into a growing market that is currently valued at approximately $72 million in Canada, according to 2016 IMS data. This launch will leverage our existing commercial ophthalmology infrastructure and build on the relationships we have established with Canadian Key Opinion Leaders and therapeutic specialists. The Company also continues to work with Health Canada on the submissions for the once-daily, extended-release versions of topiramate and oxcarbazepine, licensed from Supernus for the Canadian market.
Aequus continues to advance creative business development discussions and expects to further maximize the efficiency and revenue generated by its specialty sales force with additional complementary products.
During the reported quarter, Aequus advanced the long-acting transdermal doxylamine/pyridoxine combination patch program, AQS1303, for the treatment of nausea and vomiting in pregnancy through an initial proof of concept clinical study that was initiated in July 2017. Results from this study suggested that sustained delivery of therapeutic levels of the active ingredients through the skin over a multi-day period is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported.
The Company also received positive feedback from the US Food and Drug Administration (“FDA”) in a pre-Investigational Drug Application (“pre-IND”) meeting for the Company’s lead development program, AQS1301, a once-weekly transdermal formulation of aripiprazole. Upon review of the Company’s pre-IND submission, the FDA agreed that AQS1301 is a suitable candidate for the 505(b)2 abbreviated regulatory pathway for approval in the United States. Aequus has also since expanded the patent portfolio for this program with a patent granted in China which adds to the previously issued/allowed countries or regions namely the United States, Russia, Mexico, Japan, Australia and Canada with several other major markets pending.
Aequus has accelerated business development discussions for AQS1301 and AQS1303 in response to inbound interest following the successful completion of both Proof of Concept studies, and will look to execute regional partnerships in the first half of 2018.
In connection with the Company’s previously announced medical cannabis program, Aequus formed a collaboration with Scientus Pharma, Inc. (“Scientus”) to be the development and commercial supplier of specific cannabinoid extracts, with an option for Scientus to co-fund the development of a cannabinoid containing transdermal formulation that would be designed and optimized to address certain neurological disorders. Additionally, the Company entered into a collaboration with Ehave, Inc. (“Ehave”) to access Ehave’s bioinformatics platform, providing cost effective and clinically relevant data collection in Aequus’ anticipated clinical trials in the medical cannabis regulatory regime.
“We continue to stay focused on our growth trajectory in specialty therapeutic areas, listening to the needs of our clinical customers. Our strategy is to leverage Canadian revenues to fund new product development concepts informed by our clinician customer base, for which we would own global rights,” said Doug Janzen, CEO and Chairman of Aequus. “Our primary focus for the remainder of 2017 and 2018 is to continue to build revenues, which we expect will come from the existing base business, the Santen product launch, other potential in-licensing transactions currently under discussion, as well as the out-licensing efforts from our development programs.”
FINANCIAL STATEMENTS AND MD&A
Investors are encouraged to review Aequus’ complete Condensed Consolidated Interim Financial Statements and Management’s Discussion and Analysis (“MD&A”) for the three and nine months ended September 30, 2017, which are available on the Company’s website at www.aequuspharma.ca
and on SEDAR at www.sedar.com
ABOUT AEQUUS PHARMACEUTICALS INC.
Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus’ development stage pipeline includes several products in neurology and psychiatry with a goal of addressing the need for improved medication adherence through enhanced delivery systems. With a focus in neurology and other specialty areas, our most recent addition to the development pipeline was a long-acting form of medical cannabis, where there is a high need for a consistent, predictable and pharmaceutical-grade delivery of products for patients. Aequus intends to commercialize its internal programs in Canada alongside its current portfolio of marketed established medicines and will look to form strategic partnerships that would maximize the reach of its product candidates worldwide. Aequus plans to build on its Canadian commercial platform through the launch of additional products that are either created internally or brought in through an acquisition or license; remaining focused on highly specialized therapeutic areas. For further information, please visit www.aequuspharma.c
FORWARD-LOOKING STATEMENT DISCLAIMER
This release may contain forward-looking statements or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “potential” and similar expressions. Forward- looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements include but are not limited to statements relating to: the implementation of our business model and strategic plans; the Company’s expected revenues; the timing of public listings; the timing of results of the Company’s transdermal pyridoxine/doxylamine program’s Proof of Concept clinical study; the Company’s potential regional partnerships for its internal programs; the timing of public reimbursement decisions for VistitanTM; the regulatory requirements for the its transdermal aripiprazole program; and the Company’s expectations regarding the medical cannabis portfolio. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Aequus, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements. In making the forward looking statements included in this release, the Company has made various material assumptions, including, but not limited to: obtaining positive results of clinical trials; obtaining regulatory approvals; general business and economic conditions; the Company’s ability to successfully outlicense or sell its current products and in-license and develop new products; the assumption that the Company’s current good relationships with its manufacturer and other third parties will be maintained; the availability of financing on reasonable terms; the Company’s ability to attract and retain skilled staff; market competition; the products and technology offered by the Company’s competitors; and the Company’s ability to protect patents and proprietary rights. In evaluating forward looking statements, current and prospective shareholders should specifically consider various factors set out herein and under the heading “Risk Factors” in the Company’s Annual Information Form dated April 29, 2016, a copy of which is available on Aequus’ profile on the SEDAR website at www.sedar.com, and as otherwise disclosed from time to time on Aequus’ SEDAR profile. Should one or more of these risks or uncertainties, or a risk that is not currently known to us materialize, or should assumptions underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by applicable securities laws. Investors are cautioned that forward-looking statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward looking statements.
VistitanTM: Trademark owned or used under license by Sandoz Canada Inc.