Creating a Leading Urology & Men’s
- Acerus to have access to two significant and growing addressable markets that represent more than 40 million people in
the United States alone - On a combined pro- forma basis, Acerus is projected to achieve peak net revenue of more than
$500 million USD in 2030 - Acerus acquires Serenity’s future pipeline portfolio
Transaction Details
Within 90 days of the effectiveness of the acquisition (the “Acquisition”), Acerus will pay a
Two additional one-time equity-based sales milestones valued at
Serenity stockholders will also receive tiered low double-digit Contingent Sales Payments, paid in cash, equal to a percentage of
The boards of directors of both companies have approved the transaction.
Strategic Rationale and Financial Benefits of the Transaction
The combined company will have a significantly increased presence in the prescription urology and men’s health markets. Acerus’ portfolio will include two FDA-approved products, Noctiva™ and Natesto®, that address large patient populations as well as a pipeline of future opportunities related to Noctiva™. There is significant commercial and operational synergy between the two products. The combined products leverage similar physician call points – primarily urologists and primary care physicians, retail pharmacy distribution and commercial and government payors. As a result, Acerus management feels that there will be a significant opportunity to scale its existing commercial infrastructure to drive growth in the combined portfolio.
An estimated 40 million Americans experience nocturia (the need to urinate 2 or more times per night) and approximately 3 million of these people are under a physician’s care and currently receiving pharmaceutical treatment for their nocturia2,3. Over 8 million prescriptions were written in 2021 in
In order to fund the up-front fee, required sales force expansion, marketing investment (including direct to consumer), growth of the existing Natesto business, and resumption of Noctiva™ production (which is currently expected to be completed by the fourth quarter of 2022), Acerus expects to have to raise an estimated
“This is a truly transformative transaction, elevating Acerus into a leading specialty pharmaceutical company positioned for what we expect to be an accelerated path to profitability, continued revenue growth and further business diversification,” said
Dr.
This section and this press release contain forward-looking information. Please see notice regarding forward-looking statements below. These statements are subject to certain key expectations and assumptions and are subject to various risks and uncertainties which could cause actual results to differ materially from the anticipated results or expectations expressed in this press release.
Additional Information
The combined company will continue to be led by
“We are pleased to welcome Dr.
The Acquisition is currently expected to close on
TSX Shareholder Approval Requirements
Completion of the Acquisition could result in the issuance of up to 1,533,642,008 Common Shares assuming the First Commercial Sale Shares and each tranche of the Sales Milestone Shares become issuable to the Serenity stockholders in accordance with the terms of the Definitive Agreement (and the Sales Milestone Shares are issued at the floor price) representing approximately 99.74% of Acerus’ currently issued and outstanding Common Shares. Section 611(c) of the TSX Company Manual requires that shareholder approval be obtained where the number of securities issued or issuable in payment of the purchase price for an acquisition exceeds 25% of the number of securities of the listed issuer which are outstanding, on a non-diluted basis. Pursuant to section 604(d) of the TSX Company Manual, holders of more than 50% of the votes attached to the Common Shares have delivered a written consent to the issuance of the Common Shares that may become issuable in accordance with the terms of the Definitive Agreement, which has been provided to the TSX to satisfy shareholder approval for the potential issuance of the Common Shares to the Serenity stockholders under the Definitive Agreement.
As of the date hereof, Acerus has 1,537,588,081 Common Shares issued and outstanding on a non-diluted basis. Serenity has two key securityholders, who Acerus expects will receive approximately 33.35% and 25.94%, respectively, of the Common Shares issuable to Serenity securityholders in connection with the Acquisition. Assuming the full number of Common Shares issuable under the Definitive Agreement become issuable (which includes issuance of the Sales Milestone Shares at the floor price) and there are no other changes to Acerus’ issued and outstanding Common Shares as of the date hereof, such key securityholders of Serenity would own approximately 16.65% and 12.95% of Acerus’ issued and outstanding Common Shares at such time. Based on the same assumptions,
About Acerus
Acerus Pharmaceuticals Corporation is a specialty pharmaceutical company focused on the commercialization and development of innovative prescription products that improve patient experience, with a primary focus in the field of men’s health. The Company commercializes its products via its own salesforce in
Acerus’ shares trade on TSX under the symbol ASP and on OTCQB under the symbol ASPCF. For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.
About Serenity
Founded in 2006 and located in
About NATESTO® (Testosterone) Nasal Gel
Natesto is a nasal gel formulation of testosterone developed by
Notice regarding forward-looking statements
Except for statements of historical fact relating to Acerus or Serenity, certain statement contained in this press release constitute forward-looking information, future oriented financial information or financial outlooks (collectively “forward-looking information”) within the meaning of applicable securities laws. Forward-looking information may be contained in this document and other public filings of Acerus. Forward-looking information relates to statements concerning Acerus and the combined company’s outlook, anticipated events or results, statements as to Acerus’ management expectations with respect to the Acquisition, including the completion thereof, and statements with respect to the combined company including expected net revenues of the combined company and in some cases, can be identified by terminology such as “may”, “will”, “could”, “should”, “expect”, “plan”, “forecast”, “anticipate”, “believe”, “intend”, “estimate”, “projects”, “predict”, “potential”, “continue” or other similar expressions concerning matters that are not historical facts.
Forward-looking information in this press release are based on certain key expectations and assumptions made by Acerus, including expectations and assumptions concerning the closing of the Acquisition. Although Acerus believes that the expectations and assumptions on which such forward-looking information are based are reasonable, undue reliance should not be placed on the forward-looking information because Acerus can give no assurance that they will prove correct. Forward-looking information are subject to various risks and uncertainties which could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this press release. The key risks and uncertainties include, but are not limited to, the Acquisition not closing as anticipated; delay or failure to resume the production of Noctiva; failure to raise sufficient capital, which could impede the ability to properly launch Noctiva and thus achieve anticipated revenue targets for Acerus; failure to maintain ongoing production of Natesto or Noctiva due to quality issues, supply chain disruption or events at the contract manufacturers that produce both products; failure to achieve or maintain adequate and competitive commercial and government reimbursement for either of Natesto and Noctiva with key payers in the US or other key markets; failure to attain market acceptance and anticipated market shares for the combined company’s products; failure to retain key personnel or failure to replace departures in a timely manner; failure of the combined company to integrate and achieve expected synergies; the profitability and viability of the combined entity; the ability of Acerus and the combined company to continue as a going concern; the anticipated ability of Acerus to raise the capital required to fund the payment of the purchase price and the operations of the combined company; the continued commercialization and sales of products; market acceptance of the company’s products; generic entrance risk and intellectual property risks; risks associated with the company’s marketing and distribution and reliance on third party manufacturers and suppliers; risks related to product safety or efficacy concerns which could result in litigation, regulatory action or product recalls or withdrawals; governmental and regulatory requirements and actions by governmental authorities, including changes in government policy, tax, prescription drug pricing and rebates and other laws or regulations and interpretations thereof; developments with respect to the COVID-19 pandemic, including the duration, severity and scope of the pandemic and potential impacts on operations and supply chains; the fact that the combined company will continue to have a controlling shareholder; and other risk factors detailed from time to time in Acerus’ reports filed with the Canadian securities regulatory authorities. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated
Company Contact
ir@aceruspharma.com
Investor Relations Contact
Acerus Investor Relations
(646) 438-9385
cwitty@darrowir.com
References :
- Noctiva™
U.S. package insert - Leslie SW, Sajjad H, Singh S. Nocturia. [Updated 2021 Aug 12]. In: StatPearls [Internet].
Treasure Island (FL):StatPearls Publishing ; 2021 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK518987/ - Int Neurourol J. 2016 Dec;20(4):304-310. doi: 10.5213/inj.1632558.279. Epub 2016 Dec 26
Symphony Health prescription data
Source:
2022 GlobeNewswire, Inc., source