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Acerus Reports Fiscal 2021 Second Quarter Financial Results

08/10/2021
Revenue Triples after Buyback of US Rights for NATESTO®

TORONTO, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Acerus Pharmaceuticals Corporation (“Acerus” or the “Company”) (TSX:ASP; OTCQB:ASPCF) today reported its financial results for the three and six-month period ended June 30, 2021. Unless otherwise noted, all amounts are in US dollars and are prepared in accordance with International Financial Reporting Standards (“IFRS”).

Second Quarter Highlights

  • The second quarter included full US product sales for NATESTO®, following the Company’s buyback of the rights from Aytu BioPharma on April 1, 2021, resulting in a 219% increase in product revenue compared to the second quarter of fiscal 2020
  • Total NATESTO® prescriptions (“TRx”) grew by 45% in the second quarter of fiscal 2021 compared to the prior-year period
  • Within the urology segment, NATESTO® TRx grew 63% year-over-year, reflecting the effectiveness of Acerus’ commercial activities
  • The Company announced a NATESTO® revenue-sharing agreement with Amneal Pharmaceuticals effective July 2021, leveraging Amneal’s extensive relationships with endocrinology healthcare providers in the US
  • Acerus announced a new pharmacy benefit manager contract for NATESTO® in the US, increasing coverage to 85% of commercial lives
  • The Company completed a $15 million subordinated secured loan facility (the “Loan Facility”) providing capital to execute many ongoing growth initiatives

“Acerus posted strong results this quarter following the strategic steps taken to accelerate our expansion in the US market this year,” said Ed Gudaitis, President and Chief Executive Officer of Acerus. “Revenue was triple that of the 2020 second quarter due to our buyback of the NATESTO rights from Aytu, allowing us to leverage our growing market position and book revenue when realized. In addition, we posted gross profit of $0.5 million and are executing a plan that should continue this solid performance during the remainder of fiscal 2021. While investing in marketing and R&D to strengthen our presence in the US, we expect such moves will pay off handily in higher top line growth. Prescriptions are up, we’ve implemented a revenue-sharing agreement with Amneal, and we now have increased PBM coverage – all leading to a positive outlook for this year and beyond.”

Summary of Results for the Three Months Ended June 30, 2021 compared to the Three Months Ended June 30, 2020, unless otherwise noted

The Company reported revenue of $0.6 million for the second quarter of 2021 compared with $0.2 million in the prior-year period, an increase of 219%. The improvement was primarily due to the assumption of full NATESTO® product sales and revenue recognition as a result of purchasing the rights from Aytu Biopharma on April 1, 2021, as previously reported.

Gross profit was $0.5 million in the second quarter of 2021 versus a gross loss of $0.1 million in 2020. The year-over-year increase reflect higher sales in 2021, while 2020 results included the impact of fixed, non-cash costs of $0.2 million related to the amortization of intangible assets and depreciation of property and equipment.

Second quarter research and development ("R&D") expenses were $0.9 million versus $0.4 million in the prior-year period. The increase was primarily due to higher clinical trials-related expense for NATESTO® in the US, including an Ambulatory Blood Pressure Monitoring Trial that was launched in the first quarter of 2021 (and expected to last until the end of 2022).

Selling, general and administrative expense (“SG&A”) increased by $1.7 million, to $6.3 million, largely reflecting $0.7 million of marketing and advertising campaign expenses related to US growth initiatives and a $0.7 million charge to write off the accrued receivables related to the present value of the expected royalty stream from the sale of ESTRACE® recorded in the fourth quarter of 2020.

Second quarter earnings before interest, tax, depreciation and amortization (“EBITDA”)1 was a loss of $6.5 million compared to a loss of $4.9 million in the second quarter of 2020. Adjusted EBITDA1 was a loss of $6.2 million for the current year second quarter compared to a loss of $4.7 million in the prior-year period.

The Company incurred a net loss of $7.1 million, or $(0.00) per share, for the quarter compared to a loss of $5.6 million, or $(0.01) per share, in the second quarter of 2020.

Cash as of June 30, 2021 was $2.6 million compared with $9.2 million on December 31, 2020, reflecting proceeds of $7.0 million drawn on the $15.0 million subordinated demand loan facility with First Generation Capital, offset by cash used in operations as well as principal and interest repayments totaling $1.6 million on the senior debt with SWK Funding LLC.

COMPANY UPDATES AND OUTLOOK

NATESTO®

With the full buy back of NATESTO® rights for the US market completed April 1, 2021, the Company continues to execute on its strategy focusing on the US market. Acerus also announced in the second quarter a NATESTO® co-promotion agreement with Amneal Pharmaceuticals (“Amneal”) that leverages that company’s extensive relationships with endocrinology healthcare providers in the US. Under the terms of the agreement, Amneal will sell NATESTO® to its existing endocrinology targets through June 30, 2024. In compensation for such marketing efforts, Amneal will receive a commission for most of the net profits attributed to endocrinology targets in the three active promotional years, with Acerus retaining a low double-digit percentage of such net profits during this time. Amneal will also receive a three-year trailing royalty following the active promotion period, with compensation to Amneal decreasing from a majority of the net profits to a minority of the net profits. The co-promotion agreement is now live (effective July 1, 2021), and Amneal reps are actively involved in selling to their call points.

On June 28, 2021, the Company announced a significant improvement in commercial insurance coverage for NATESTO® in the United States. A leading national Pharmacy Benefits Manager (“PBM”) added NATESTO® to its Preferred Drug List as a Preferred Brand, allowing for enhanced patient access and potentially increased physician prescriptions to the more than 13 million men in the US who have been diagnosed with hypogonadism.

Commercial preparations continue regarding the reintroduction of NATESTO® into the Canadian market. The Company currently expects to re-launch NATESTO® in Canada in the fourth quarter

RECIPHARM LITIGATION

On June 18, 2020, Acerus announced it had commenced litigation against Recipharm Limited (“Recipharm”), a wholly-owned subsidiary of Recipharm AB, in the Commercial Court of London. Acerus previously alleged that the suspension of Recipharm’s manufacturing license in August 2018 was a violation of its contractual obligations and led to a shortage of Estrace® in Canada. On June 15, 2021, the Company won at a preliminary issue trial in which Recipharm alleged that Acerus’ claim for damages was barred by the terms of the companies’ manufacturing contract. In agreeing with Acerus that its claim for damages was not barred, the Commercial Court of London directed the matter to proceed to a full trial in the coming months. Recipharm was granted permission to appeal the court’s decision on August 3, 2021 with the main proceedings being stayed pending appeal.

avanafil

Health Canada’s review of the avanafil New Drug Submission (“NDS”) is ongoing, and the Company continues to respond to questions and clarification requests. As disclosed in the Company’s 2020 fourth quarter earnings report, the review process can take up to a year from receipt of the NDS (December 2020).

Conference Call
Shareholders are reminded that the conference call to discuss the Company’s results for the three- and six-month period ending June 30, 2021 will be held on today, August 10, 2021 at 10:00 a.m. Eastern Time. To access the call live, please dial 416-406-0743 or 1-800-952-5114 and use access code 2381183#. Listeners are encouraged to dial in 10 minutes before the call begins to avoid delays.

A replay of the conference call will be available until 11:59 p.m. Eastern Time on Tuesday, August 17, 2021 by dialing 905-694-9451 or 1-800-408-3053, using access code: 9081508#.

About Acerus
Acerus Pharmaceuticals Corporation is a Canadian-based 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 the United States and Canada, and through a global network of licensed distributors in other territories.

Acerus’ shares trade on TSX under the symbol ASP and on the OTCQB under the symbol ASPCF. For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.

1 Non-IFRS Financial Measures  – EBITDA and Adjusted EBITDA
The non-IFRS measures included in this press release are not recognized measures under IFRS and do not have a standardized meaning prescribed by IFRS and may not be comparable to similar measures presented by other issuers. When used, these measures are defined in such terms as to allow the reconciliation to the closest IFRS measure. These measures are provided as additional information to complement those IFRS measures by providing further understanding of our results of operations from our perspective. Accordingly, they should not be considered in isolation nor as a substitute for analysis of our financial information reported under IFRS. Despite the importance of these measures to management in goal setting and performance measurement, we stress that these are non-IFRS measures that may have limits in their usefulness to investors.

We use non-IFRS measures, such as EBITDA and Adjusted EBITDA to provide investors with a supplemental measure of our operating performance and thus highlight trends in our core business that may not otherwise be apparent when relying solely on IFRS financial measures. We also believe that securities analysts, investors and other interested parties frequently use non-IFRS measures in the valuation of issuers. We also use non-IFRS measures in order to facilitate operating performance comparisons from period to period, prepare annual operating budgets, and to assess our ability to meet our future debt service, capital expenditure and working capital requirements.

The definition and reconciliation of EBITDA and Adjusted EBITDA used and presented by the Company to the most directly comparable IFRS measures follows below:

EBITDA is defined as net (loss)/income adjusted for income tax, depreciation of property and equipment, amortization of intangible assets, interest on long-term debt and other financing costs, interest income, licensing revenue and changes in fair values of derivative financial instruments. Management uses EBITDA to assess the Company’s operating performance.

Adjusted EBITDA is defined as EBITDA adjusted for, as applicable, royalty expenses associated with triggering events, milestones, share based compensation, impairment of intangible asset, foreign exchange (gain)/loss and the impact of charges related to a product recall. We use Adjusted EBITDA as a key metric in assessing our business performance when we compare results to budgets, forecasts and prior years. Management believes Adjusted EBITDA is an alternative measure of cash flow generation than, for example, cash flow from operations, particularly because it removes cash flow fluctuations caused by extraordinary changes in working capital. A reconciliation of net (loss)/income to EBITDA (and Adjusted EBITDA) is set out below.

    For the three months ended
June 30,
    For the six months ended
June 30,
 
      2021       2020       2021       2020  
Net loss   $ (7,070 )   $ (5,610 )   $ (19,896 )   $ (10,273 )
Adjustments:            
Amortization of intangible assets     38       179       75       358  
Depreciation of property and equipment     221       64       443       128  
Depreciation of right of use asset     3       12       3       24  
Interest expense and other financing costs*     408       382       700       1,228  
Interest income     (2 )     (32 )     (7 )     (63 )
Change in fair value of derivative     (57 )     59       12       (104 )
Loss on modification of debt     -         64       -  
EBITDA   $ (6,459 )   $ (4,946 )   $ (18,606 )   $ (8,702 )
             
Termination Fees     50       -       6,254       -  
Share based compensation     176       203       467       248  
Foreign exchange (gain) loss     (25 )     151       (40 )     (93 )
Charges related to product recall     -       (71 )     -       (71 )
Gain on sale of property and equipment     56       -       56       -  
Adjusted EBITDA   $ (6,202 )   $ (4,663 )   $ (11,869 )   $ (8,618 )
             

Notice Regarding Forward-Looking Statements
Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including with respect to the commercial performance of NATESTO® globally and in the U.S., and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 10, 2021 which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

Contacts:
Company Contact
ir@aceruspharma.com

Chris Witty
Acerus Investor Relations
(646) 438-9385
cwitty@darrowir.com

       
Acerus Pharmaceuticals Corporation
Condensed Interim Consolidated Statements of Financial Position
As at June 30, 2021 and December 31, 2020
Unaudited
(expressed in thousands of U.S. dollars)
       
    June 30,
2021

    December 31,
2020

 
       
ASSETS      
       
Current assets      
Cash   $ 2,603     $ 9,153  
Trade and other receivables     1,321       528  
Contract asset     -       936  
Inventory     2,463       2,313  
Prepaid and other assets     1,218       1,104  
Total current assets     7,605       14,034  
       
Property and equipment, net     375       806  
Right of use asset     317       -  
Intangible assets, net     2,067       2,142  
Total assets   $ 10,364     $ 16,982  
       
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)          
       
Current liabilities      
Accounts payable and accrued liabilities   $ 6,525     $ 5,435  
Termination fee payable     2,670       -  
Current portion of long-term debt     2,120       1,439  
Current portion of lease liability     4       229  
Total current liabilities     11,319       7,103  
       
Termination fee payable     2,798       -  
Lease liability     307       -  
Long-term debt     4,978       6,580  
Subordinated Loan Facility     5,747       -  
Derivative financial instruments     156       139  
Total liabilities     25,305       13,822  
       
Shareholders' equity (deficit)      
Share capital   $ 198,163     $ 198,163  
Contributed surplus     15,230       13,435  
Accumulated other comprehensive loss     (13,949 )     (13,949 )
Deficit     (214,385 )     (194,489 )
Total shareholders' equity (deficit)     (14,941 )     3,160  
Total liabilities & shareholders' equity (deficit)   $ 10,364     $ 16,982  


Acerus Pharmaceuticals Corporation
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
For the three and six months ended June 30, 2021 and 2020
Unaudited
(expressed in thousands of U.S. dollars, except per share and share data)
    For the three months ended
June 30,
  For the six months ended
June 30,
      2021       2020       2021       2020  
                 
Revenue                
Product revenue   $ 562     $ 176     $ 796     $ 321  
Termination Fees     (50 )     -       (6,254 )     -  
      512       176       (5,458 )     321  
Cost of goods sold     45       224       236       425  
Gross margin (loss)     467       (48 )     (5,694 )     (104 )
                 
Expenses                
Research and development     928       400       1,901       1,022  
Selling, general and administrative     6,285       4,602       11,572       8,179  
Total operating expenses     7,213       5,002       13,473       9,201  
Operating loss     (6,746 )     (5,050 )     (19,167 )     (9,305 )
                 
Other expenses(income)                
Interest on long-term debt and other financing costs     408       382       700       1,228  
Interest income     (2 )     (32 )     (7 )     (63 )
Foreign exchange (gain)/loss     (25 )     151       (40 )     (93 )
Change in fair value of derivative financial instruments     (57 )     59       12       (104 )
Loss on modification of debt     -       -       64       -  
Total other expenses     324       560       729       968  
Loss for the period before income taxes     (7,070 )     (5,610 )     (19,896 )     (10,273 )
                 
Income tax expense     -       -       -       -  
Net loss and comprehensive loss for the period     (7,070 )     (5,610 )   $ (19,896 )   $ (10,273 )
                 
Loss per common share                
Basic and diluted net loss per common share   $ (0.00 )   $ (0.01 )   $ (0.01 )   $ (0.01 )
                 
Weighted average common shares outstanding                
Basic and diluted     1,537,588,081       1,010,456,066       1,537,588,081       833,440,004  

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Source: Acerus Pharmaceuticals Corporation