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Acerus Reports Third Quarter and Year-to-Date Fiscal 2019 Financial Results

11/14/2019

TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (“Acerus” or the “Company”) (TSX:ASP; OTCQB:ASPCF) today reported its financial results for the three- and nine-month period ended September 30, 2019. Unless otherwise noted, all amounts are in US dollars and are prepared in accordance with International Financial Reporting Standards (“IFRS”).

Third Quarter Highlights

  • Preparing for United States launch under Amended and Restated License Agreement (“A&R Agreement) with Aytu BioScience to co-promote NATESTO® in the USA
  • Reported positive clinical study results showing that NATESTO® increases serum testosterone and improves symptoms while maintaining normal semen parameters in men with low testosterone

“In anticipation of the closing of the A&R Agreement, we have begun the process of standing-up both a US market access team and specialty sales organization to co-promote NATESTO® to the United States market. This expansion of our footprint to enter the United States market confirms our men’s health strategy and truly establishes Acerus as a globally focused company headquartered in Canada, not just a company servicing the Canadian marketplace”, said Ed Gudaitis, President and Chief Executive Officer of Acerus. “We are also excited about the results of a clinical study showing that NATESTO® increases serum testosterone and improves symptoms while maintaining normal semen parameters in men with low testosterone. This positive study, presented initially by Dr. Ranjith Ramasamy, MD, Associate Professor and Director of Reproductive Urology at the University of Miami School of Medicine, at the American Society for Reproductive Medicine Conference on October 17, 2019, and subsequently at an Acerus Key Opinion Leader presentation in New York City on October 30, 2019, clearly differentiates NATESTO® from other approved testosterone therapies. We are very excited by the outcomes of this study and will look to further develop the growing evidence-base supporting NATESTO®.”

Summary of Results for the Three Months Ended September 30, 2019 (compared to the Three Months Ended September 30, 2018 unless otherwise noted)

Total revenue in the quarter was negative $0.2 million compared to $1.6 million in the third quarter of 2018. This decline is due to a $0.8 million drop in Estrace® and UrivarxTM product revenues and the net impact of $0.6 million in Q3-2019 for returns associated with the delay in returning NATESTO® to the Canadian and South Korean markets (previously it was assumed that the product would be replaced rather than returned) and reversing the Q2-2019 $0.1 million charge to revenue discounts for incentives to customers to accept replacement product.

On August 2, 2019, we announced that we would voluntarily replace certain NATESTO® lots released in the Canadian and South Korean markets, which was expected to cause temporary shortages in those markets. We have identified four commercial lots of NATESTO® released in the Canadian and South Korean markets that were found to be non-conforming during long-term stability studies, even though such lots were fully in-specification at the time of release. This post-release non-conformity is not harmful to the patient, but may result in difficulties in dispensing. Acerus made minor modifications to the manufacturing process that appear to have resolved the previously identified issues and has produced a new commercial batch of Natesto®. On November 1, 2019, we announced that Health Canada classified the changes as level I, requiring the submission of a SNDS. Should Health Canada utilize the full regulatory allotted time for reviewing a SNDS, Acerus would expect the Revised Batch to be released in the Canadian Market in Q1-2021. In Q2-2019, we had previously impaired inventory by $0.3 million and accrued $0.5 million related to replacing products, discounts and potential returns due to the issue described above. However, due to the additional delays, the Company reversed the previous accruals related to discounts and replacement of product and has accrued $0.7 million for returns in the current quarter.

The following table indicates the revenue by product for the quarter (in US$’000s):

Difference

Q3 2019 Q3 2018

$

NATESTO®
USA

$ 80

$ 172

$ (92)

Canada

(159)

364

(523)

Rest of World

(296)

-

(296)

Total NATESTO®

(375)

536

(911)

Estrace®

203

883

(680)

UriVarxTM

5

164

(159)

Total Q3

$ (167)

$ 1,583

$ (1,750)

  • The NATESTO® Canadian business during the quarter was impacted by the reversal of the $0.1 million accrual made in Q2-2019 on discounts the Company anticipated to give to wholesalers for replacement product and the expense of $0.3 million related to the estimated returns for the recalled lots in Q3-2019. The NATESTO® Rest of World business also reflects the impact of estimated returns for the recalled lots in Q3-2019 for South Korea. The US revenue decline reflects the change in accounting policy regarding revenue recognition on US based revenue announced in the first quarter of 2019.
  • The decline in ESTRACE® revenue reflects the conservation measures management implemented due to the previously announced manufacturing license suspension at our contract manufacturer. The Company is working to transition ESTRACE® production to a new contract manufacturer with the expectation that new shipments, and the associated return in revenues to more normalized revenues should begin by the second quarter of 2020.
  • The revenue decline related to UriVarxTM was due to the Company and the manufacturer mutually agreeing to terminate the distribution and license agreement for this product for the Canadian market in the second quarter of 2019.

Gross margin declined by $0.8 million to negative $0.04 million compared to the prior year quarter. The current figure reflects the accrual for product returns described above and the reversal of the $0.4 million charge to cost of goods made in Q2-2019 when it was expected that the Company would replace the recalled NATESTO® product.

Selling, general and administrative expenses (“SG&A”) increased to $3.2 million from $2.2 million in the prior year period. The current quarter reflects costs of $2.1 million in anticipation of the NATESTO® United States A&R Agreement closing and subsequent launch. Absent this charge, SG&A expenses were $1.1 million or 50% lower than the comparable prior year period, reflecting decreased marketing and selling expenses related to NATESTO® Canada and UriVarxTM and decreased salaries and benefits costs due to reductions in commercial headcount and reductions in bonus accrual. The Company will continue to review expenses and make adjustments where necessary in light of the recent recall and SNDS requirement. In particular, Acerus will be streamlining its future operating expenses to focus on the following key priorities: 1) the standing up of the US organization in anticipation of the “go-live” of the A&R Agreement, 2) the approval by Health Canada and launch of avanafil in the Canadian market, 3) supporting our global partners who are launching NATESTO® in their respective markets and 4) strengthening the management of our third-party manufacturing network.

Research and development ("R&D") expense was $0.6 million for the current quarter, a slight decline from the $0.8 million for the prior year period.

Earnings before interest, tax, depreciation and amortization (“EBITDA”)1 was a loss of $3.7 million compared to an EBITDA loss of $1.6 million for the prior year quarter. Adjusted EBITDA1, was a loss of $3.4 million for the quarter compared to a loss of $1.5 million for the prior year period.

The Company incurred a net loss of $4.6 million or $(0.02) per share for the quarter compared to a loss of $2.9 million or $(0.01) per share for the third quarter of 2018.

Cash as of September 30, 2019 was $4.1 million compared with $3.8 million on December 31, 2018, reflecting the proceeds of a CDN$4.5 million private placement in Q1-2019, and a US$5.0 million subordinated debt facility entered into in Q3-2019 between the Company and First Generation Capital Inc., a company affiliated with the Chairman of the Board of Directors of the Company, offset by cash used in operations.

Summary of Results for the Nine Months Ended September 30, 2019 (compared to the Nine Months Ended September 30, 2018 unless otherwise noted)

  • Total revenue for the nine months ended September 30, 2019 and 2018 was $3.3 million and $5.3 million, respectively, reflecting a decline in product revenue of $1.9 million and a decline in licensing and other revenue of $0.2 million.
  • The period-over-period product sales decline of $1.9 million was primarily due to a $1.7 million decrease in ESTRACE® sales (reflecting the conservation measures noted previously), a $0.3 million decrease in NATESTO® Canada sales due to the recall issues discussed above, and a less than $0.1 million decrease in sales of UriVarxTM due to the termination of the agreement in June 2019, offset by a $0.1 million increase in NATESTO® US sales due to higher Tier 2 revenues, which offset the revenues earned in 2018 related to two shipments of inventory to the US marketing partner.
  • Gross margin was $1.4 million compared with a negative gross margin of $4.2 million in the prior year period. 2018’s negative gross margin reflects the $6.7 million Mattern Pharma AG royalty buyout accrual recorded in the first and second quarter of 2018. Gross margin in the current period includes a $0.7 million charge to revenue related to estimated returned products and a $0.3 million impairment of inventory related to the NATESTO® recall and SNDS described above.
  • Research and development ("R&D") expenses were $2.3 million for the nine months ended September 30, 2019, an increase of $0.5 million from the $1.8 million from the prior year period. This reflects increased clinical trial costs as well as the Health Canada filing fee for avanafil recorded in the first quarter of 2019.
  • Selling, general and administrative expenses (“SG&A”) were $9.6 million for the nine months ended September 30, 2019, an increase of $3.4 million from the $6.2 million reported in comparable 2018 period. This increase is principally due to a) the $2.5 million non-cash impairment charge for the carrying value of the ESTRACE® intangible asset reflected in the first quarter of 2019 and b) $2.1 million in costs incurred in 2019 related to the anticipated launch of the A&R Agreement between Acerus and Aytu Biosciences, offset by lower selling and marketing expenses.
  • EBITDA1 loss for the nine months ended September 30, 2019 was $9.6 million compared with an EBITDA loss of $11.1 million for the prior year period, reflecting the adjustments noted above. Adjusted EBITDA1 for the nine months ended September 30, 2019 was a loss of $6.0 million compared to loss of $3.8 million for the prior year period.
  • The Company incurred a net loss for the nine months ended September 30, 2019 of $12.2 million or $(0.05) per share compared to $13.7 million or $(0.06) for the same prior year periods.

NATESTO® USA UPDATE

As indicated above, the Company and Aytu Bioscience jointly announced on July 30, 2019, that they had signed an amended and restated license agreement to allow Acerus to enter the US market directly and co-promote NATESTO®to the specialist (urology and endocrinology) market. Under the terms of the new agreement, Aytu returns the NDA for NATESTO® in the US back to Acerus. Going forward, Acerus will assume all regulatory and clinical responsibilities and costs for the product in the US Acerus will take on a more expansive role in matters such as US marketing, reimbursement and medical strategy as part of the companies’ joint commercialization committee. Aytu will retain its primary care sales force and will continue to book all product net revenue while serving as the exclusive US supplier of NATESTO® to wholesalers, pharmacies and other customers that receive a direct shipment. Financial payments will be based upon a tiered level of net revenue, post cost of goods sold (COGS), based on annual sales performance in the respective Acerus and Aytu Sales Channels. This transaction is conditional on Acerus raising at least US$10 million in any combination of debt or equity by no later than January 29, 2020. In anticipation of the condition being satisfied, the Company has begun working with its partner, Syneos Health, to facilitate a launch by Acerus in early 2020.

Conference Call

Shareholders are reminded that the conference call to discuss the Company’s results for the three- and nine-month period ending September 30, 2019 will be held on Thursday, November 14, 2019 at 8:30 a.m. Eastern Time. To access the call live, please dial 416-340-2219 or 1-800-478-9326. 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 Thursday, November 21, 2019 by dialing 905-694-9451 or 1-800-408-3053, using access code: 2401991#.

About Acerus
Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded 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 Canada, and through a global network of licensed distributors in the US and 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
September 30,
For the nine months ended
September 30,

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net (loss)

$

(4,612

)

$

(2,871

)

$

(12,246

)

$

(13,735

)

Adjustments:
Income tax

 

-

 

 

2

 

 

-

 

 

2

 

Amortization of intangible assets

 

177

 

 

447

 

 

642

 

 

1,300

 

Depreciation of property and equipment

 

64

 

 

64

 

 

191

 

 

193

 

Depreciation of right of use asset

 

12

 

 

-

 

 

35

 

 

-

 

Interest on long-term debt and other financing costs*

 

702

 

 

718

 

 

1,868

 

 

1,276

 

Interest income

 

(5

)

 

(3

)

 

(6

)

 

(12

)

Change in fair value of derivative

 

(25

)

 

2

 

 

(64

)

 

(88

)

EBITDA

$

(3,687

)

$

(1,641

)

$

(9,580

)

$

(11,064

)

 
Licensing and other revenue

 

-

 

 

-

 

 

-

 

 

(150

)

Royalty expense/Buyout

 

-

 

 

-

 

 

-

 

 

6,680

 

Share based compensation

 

57

 

 

111

 

 

163

 

 

337

 

Foreign exchange loss/(gain)

 

91

 

 

48

 

 

(94

)

 

353

 

Charges related to product recall

 

184

 

 

-

 

 

976

 

 

-

 

Impairment loss on intangible asset

 

-

 

 

-

 

 

2,536

 

 

-

 

Adjusted EBITDA

$

(3,355

)

$

(1,482

)

$

(5,999

)

$

(3,844

)

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 ability of Acerus to obtain regulatory approval for avanafil, LidbreeTM, and ElegantTM, to continue to successfully commercialize NATESTO® and ESTRACE®, and to be successful in its early stage R&D initiatives (including its cannabinoid initiative), 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 (“AIF”) dated March 4, 2019 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.

Acerus Pharmaceuticals Corporation
Condensed Interim Consolidated Statement of Financial Position
As at September 30, 2019 and December 31, 2018
Unaudited
(expressed in thousands of U.S. dollars)
 
September 30,
2019
December 31,
2018
 
ASSETS
 
Current assets
Cash

$ 4,094

$ 3,829

Trade and other receivables

308

1,113

Contract asset

536

-

Inventory

1,574

2,506

Prepaid and other assets

988

176

Total current assets

7,500

7,624

 
Property and equipment, net

1,106

1,267

Right of use asset

270

-

Intangible assets, net

5,009

7,933

Total assets

$ 13,885

$ 16,824

 
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)
 
Current liabilities
Accounts payable and accrued liabilities

$ 8,302

$ 5,619

Current portion of deferred lease inducement

-

46

Current portion of lease liability

94

-

Total current liabilities

8,396

5,665

 
Accrued liabilities

-

2,462

Deferred lease inducement

-

254

Lease liability

525

-

Long-term debt

13,417

8,287

Derivative financial instruments

355

227

Total liabilities

22,693

16,895

 
Shareholders' (deficit)
Share capital

$ 158,402

$ 154,737

Warrants

1,420

1,420

Contributed surplus

11,348

11,500

Accumulated other comprehensive loss

(13,796)

(13,851)

Deficit

(166,182)

(153,877)

Total shareholders'(deficit)

(8,808)

(71)

Total liabilities & shareholders' (deficit)

$ 13,885

$ 16,824

Acerus Pharmaceuticals Corporation
Condensed Interim Consolidated Statement of Loss and Comprehensive Loss
For the three and nine months ended September 30, 2019 and 2018
Unaudited
(expressed in thousands of U.S. dollars, except per share and share data)
For the three months ended,
September 30,
For the nine months ended,
September 30,

2019

2018

2019

2018

 
Revenue
Product revenue

$ (167)

$ 1,583

$ 3,254

$ 5,159

Licensing and other revenue

-

-

-

150

(167)

1,583

3,254

5,309

Cost of goods sold

(124)

777

1,847

2,833

Royalty buyout

-

-

-

6,680

Gross margin

(43)

806

1,407

(4,204)

 
Expenses
Research and development

622

751

2,307

1,827

Selling, general and administrative

3,184

2,159

9,642

6,173

Total operating expenses

3,806

2,910

11,949

8,000

Operating loss

(3,849)

(2,104)

(10,542)

(12,204)

 
Other expenses/(income)
Interest on long-term debt and other financing costs

702

718

1,868

1,276

Interest income

(5)

(3)

(6)

(12)

Foreign exchange (gain)/loss

91

48

(94)

353

Change in fair value of derivative financial instruments

(25)

2

(64)

(88)

Total other expenses

763

765

1,704

1,529

Loss for the period before income taxes

(4,612)

(2,869)

(12,246)

(13,733)

 
Income tax expense

-

2

-

2

Net loss for the period

(4,612)

(2,871)

$ (12,246)

$ (13,735)

 
Other comprehensive income, net of income tax
Foreign currency translation adjustment

11

8

55

99

Total comprehensive loss for the period

(4,601)

(2,863)

$ (12,191)

$ (13,636)

 
Loss per common share
Basic and diluted net loss per common share

$ (0.02)

$ (0.01)

$ (0.05)

$ (0.06)

 
Weighted average common shares outstanding
Basic and diluted

261,225,290

235,262,972

252,905,143

220,798,110

Acerus Pharmaceuticals Corporation
Condensed Interim Consolidated Statement of Cash Flows
For the nine months ended September 30, 2019 and 2018
Unaudited
(expressed in thousands of U.S. dollars)
 
September 30,
2019
September 30,
2018
 
Operating activities:
Net loss for the period

$ (12,246)

$ (13,735)

Items not affecting cash:
Adjustment for unrealized foreign exchange (gain)/loss

(190)

361

Amortization of intangible assets

642

1,300

Depreciation of property and equipment

191

193

Depreciation of right of use asset

35

-

Amortization of deferred leasehold inducement

-

(37)

Interest on long-term debt and other financing costs

1,868

1,276

Change in fair value of derivative financial instruments

(64)

(88)

Share based compensation

163

337

Gain on disposal of property and equipment

(5)

-

Impairment on intangible asset

2,536

-

Inventory impairment

316

-

Net changes in non-cash working capital items related to operating activities:
Trade and other receivables

994

476

Contract asset

(694)

-

Inventory

638

45

Prepaids and other assets

(611)

(113)

Accounts payable and accrued liabilities

(478)

4,203

Licensing fee receivable

-

300

Net cash used in operating activities

(6,905)

(5,482)

 
Financing activities
Interest and financing fees paid

(1,127)

(557)

Proceeds from issuance of common shares, net of financing costs

3,350

4,374

Payment of long-term debt

-

(1,500)

Principal elements of lease payments

(59)

-

Proceeds from issuance of long-term debt

5,000

1,571

Net cash from/(used in) financing activities

7,164

3,888

 
Investing activities
Proceeds from disposition of property and equipment

5

-

Acquisition of property and equipment, net of deposits

(13)

(88)

Acquisition of product rights

(100)

(156)

Net cash used in investing activities

(108)

(244)

 
Net increase/(decrease) in cash for the period

151

(1,838)

Exchange gain/(loss) on cash

114

(87)

Cash, beginning of period

3,829

3,156

Cash, end of period

$ 4,094

$ 1,231

 

Robert Motz
Chief Financial Officer
Acerus Pharmaceuticals Corporation
rmotz@aceruspharma.com
(905) 817-8288

Source: Acerus Pharmaceuticals Corporation