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8-K - FORM 8-K - VERU INC.d536245d8k.htm

Exhibit 99.1

 

LOGO

Contact:

Kevin Gilbert 786-322-2213

Veru Reports Fiscal 2018 First-Quarter Financial Results

Company Advancing Multiple Drugs from Pipeline; First New Drug Application (NDA) Remains on Track for Submission in 2018; Two Additional NDAs Expected to be Filed in 2019; Promising Oncology Drug Data Presented at Major Medical Conference 

Company to Host Investor Conference Call on Wednesday, February 14, 2018, 8 a.m. ET

MIAMI – February 14, 2018 – Veru Inc. (NASDAQ: VERU) today announced its financial results for the fiscal 2018 first quarter ended December 31, 2017.

“We continue to advance our product development program, which has been expanded to include two recently acquired late-stage urology drugs,” said Mitchell Steiner, M.D., President and Chief Executive Officer of Veru. “The two products expand our portfolio of urology and oncology drug candidates and address large patient populations. Moreover, the FDA has agreed that for each of these two products a single bioequivalence study would be acceptable for New Drug Applications (NDA).”

“Last week, we announced positive preclinical data for our VERU-111 drug candidate; the data were presented at an American Society of Clinical Oncology Genitourinary Cancers (ASCO GU) medical conference on February 9, 2018 and we expect additional data for VERU-111 will be presented at other key medical conferences later in the year. While in early stage development, VERU-111 was highly effective at inhibiting tumor growth in prostate cancer, specifically paclitaxel resistant prostate cancer, and, we believe, has strong potential in other cancer types.”

“Importantly, we remain on track to file with the FDA the Company’s first NDA for Tamsulosin DRS in 2018. Moreover, we plan to submit two additional NDAs in 2019.”

“Turning to our financial results, which currently are primarily derived from sales of FC2, our fiscal 2018 first quarter performance continues to reflect the inconsistent procurement cycles for our two largest customers, Brazil and South Africa. Both countries have announced large new tenders for female condoms. We are optimistic about potential near-term orders for FC2 from these two large international public-sector customers. Furthermore, we are seeing measurable sales growth following the implementation of several initiatives to grow our US revenue for FC2. Our US FC2 revenues for the first four months of our 2018 fiscal year were approximately $1.5 million, which is approaching the historical average annual US FC2 revenues over the last three fiscal years of approximately $1.9 million.”

Fiscal First Quarter Results: 2018 vs. 2017

For the first quarter of fiscal 2018, net revenues were $2.6 million, compared with net revenues for the first quarter of fiscal 2017 of $3.2 million. Gross profit was $1.3 million, or 51% of net revenues, compared with $1.7 million, or 51% of net revenues, for the first quarter of fiscal 2017. Operating expenses were $8.8 million, which includes a $3.8 million charge related to the settlement of certain receivables owed by our distributor in Brazil. This compares with operating expenses of $3.5 million for the prior year first quarter, which includes non-recurring acquisition-related expenses of $826,000. Net loss was $4.3 million, or $0.08 per share, compared with $1.4 million, or $0.04 per share, for the first quarter of fiscal 2017.


Significant quarter-to-quarter variations in the Company’s results have historically resulted from the timing and shipment of large orders rather than from any fundamental changes in the business or the underlying demand for female condoms.

Conference Call Event Details

Veru Inc. will host a conference call on Wednesday, February 14, 2018 at 8 a.m. Eastern Time to review the company’s performance. Interested investors may access the call by dialing 877-317-6789 from the U.S., or 412-317-6789 from outside the U.S., and asking to join into the call.

In addition, investors may access a replay of the conference call the same day beginning at approximately noon Eastern Time by dialing 877-344-7529 for US callers, or 412-317-0088 from outside the U.S., passcode 10116643. The replay will be available for one week, after which, the recording will be available via the company’s website at https://verupharma.com/investors.

About Veru Inc.

Veru Inc. (Veru) is a biopharmaceutical company focused on urology and oncology. The company is currently developing drug product candidates: Tamsulosin DRS, slow release granules, and Tamsulosin XR capsules for lower urinary tract symptoms of benign prostatic hyperplasia (BPH) (NDA planned 2018), Solifenacin DRG, slow release granules, for overactive bladder (urge incontinence, urgency and frequency of urination) (NDA planned 2019), Tadalafil/finasteride combination capsule for restricted urination because of an enlarged prostate (NDA planned 2019), VERU-944 (cis-clomiphene citrate) for hot flashes in men associated with prostate cancer hormone treatment (planned Phase 2 in 2018), and VERU-111 a novel oral anti-tubulin cancer therapy targeting alpha & beta tubulin for a variety of malignancies, including metastatic prostate, breast, endometrial and ovarian cancers (planned Phase1/2 in 2018).

To help support these clinical development programs, the company markets and sells the PREBOOST® medicated individual wipe, which is a male genital desensitizing drug product for the prevention of premature ejaculation which is being co-promoted with Timm Medical Technologies, Inc. and the FC2 Female Condom® (now available by prescription in the US including through the virtual doctor smartphone app “HeyDoctor” at www.fc2.us.com) in the United States and through The Female Health Company Division in the Global Public Health Sector. The Female Health Company Division markets to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world. More information about Veru and its products can be found at www.verupharma.com, www.PREBOOST.com, www.fc2.us.com and www.fc2femalecondom.com. For corporate and investor-related information about the Company, please visit https://verupharma.com/investors.

“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995:

The statements in this release that are not historical fact are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements relating to the regulatory pathway to secure FDA approval of the Company’s drug candidates, the anticipated timeframe for clinical studies and FDA submissions, future demand for FC2 and potential orders of FC2 by public sector customers. Any forward-looking statements in this are based upon the Company’s current plans and strategies, and reflect the Company’s current assessment of the risks and uncertainties related to its business, and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release because of new information or future events, developments or circumstances. Such forward-looking statements are inherently subject to known and unknown risks and uncertainties. The Company’s actual results and future developments could differ materially from the results or developments expressed in, or implied by, these forward-looking statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: product demand and market acceptance; competition in the

 

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Company’s markets and the risk of new competitors and new competitive product introductions; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; risks related to the development of the Company’s product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; many of the Company’s products are at an early stage of development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including licensing risks; risks related to concentration of accounts receivable with our largest customers and the collection of those receivables; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay or restructuring; a governmental tender award indicates acceptance of the bidder’s price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount; the Company’s reliance on its international partners in the consumer sector and on the level of spending on the female condom by country governments, global donors and other public health organizations in the global public sector; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company’s production capacity, efficiency and supply constraints; risks related to the costs and other effects of litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the year ended September 30, 2017. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.

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FINANCIAL SCHEDULES FOLLOW

 

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Veru Inc.

Condensed Consolidated Balance Sheets

December 31, 2017 and September 30, 2017

 

     December 31,
2017
     September 30,
2017
 

Cash

   $ 3,572,350      $ 3,277,602  

Accounts receivable, net

     3,000,308        3,555,350  

Inventory, net

     3,067,036        2,767,924  

Prepaid expenses and other current assets

     625,497        697,097  
  

 

 

    

 

 

 

Total current assets

     10,265,191        10,297,973  

Other trade receivables

     —          7,837,500  

Other assets

     582,663        156,431  

Plant and equipment, net

     513,224        555,539  

Deferred income taxes

     12,124,000        8,827,000  

Intangible assets, net

     20,684,175        20,752,991  

Goodwill

     6,878,932        6,878,932  
  

 

 

    

 

 

 

Total assets

   $ 51,048,185      $ 55,306,366  
  

 

 

    

 

 

 

Accounts payable

   $ 2,517,371      $ 2,685,718  

Accrued expenses and other current liabilities

     2,383,628        1,441,359  

Unearned revenue

     990,016        1,014,517  

Accrued compensation

     338,136        345,987  
  

 

 

    

 

 

 

Total current liabilities

     6,229,151        5,487,581  

Other liabilities

     —          1,233,750  

Deferred rent

     68,446        131,830  
  

 

 

    

 

 

 

Total liabilities

     6,297,597        6,853,161  

Total stockholders’ equity

     44,750,588        48,453,205  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 51,048,185      $ 55,306,366  
  

 

 

    

 

 

 

 

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Veru Inc.

Condensed Consolidated Statements of Operations

Three Months Ended December 31, 2017 and 2016

 

     Three Months Ended
December 31,
 
     2017     2016  

Net revenues

   $ 2,586,613     $ 3,243,599  

Cost of sales

     1,272,574       1,591,315  
  

 

 

   

 

 

 

Gross profit

     1,314,039       1,652,284  

Operating expenses

     8,750,620       3,526,974  
  

 

 

   

 

 

 

Operating loss

     (7,436,581     (1,874,690

Interest and other expense, net

     (13,169     (9,621

Foreign currency transaction loss

     (53,455     (11,939
  

 

 

   

 

 

 

Loss before income taxes

     (7,503,205     (1,896,250

Income tax benefit

     (3,246,053     (530,069
  

 

 

   

 

 

 

Net loss

   $ (4,257,152   $ (1,366,181
  

 

 

   

 

 

 

Net loss per basic and diluted common share outstanding

   $ (0.08   $ (0.04

Basic and diluted weighted average common shares outstanding

     53,154,076       30,976,140  

 

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Veru Inc.

Condensed Consolidated Statements of Cash Flows

Three Months Ended December 31, 2017 and 2016

 

     Three Months Ended
December 31,
 
     2017     2016  

Net loss

   $ (4,257,152   $ (1,366,181

Adjustments to reconcile net loss to net cash provided by operating activities:

    

Depreciation and amortization

     44,229       89,284  

Amortization of intangible assets

     68,816       26,729  

Share-based compensation

     207,454       317,311  

Warrants issued

     —         542,930  

Deferred income taxes

     (3,297,000     (591,573

Loss on settlement of accounts receivable

     3,764,137       —    

Other

     (5,000     4,469  

Changes in current assets and liabilities, net of effects of acquisition of a business:

     3,771,178       2,142,996  
  

 

 

   

 

 

 

Net cash provided by operating activities

     296,662       1,165,965  

Net cash used in investing activities

     (1,914     (65,623
  

 

 

   

 

 

 

Net increase in cash

     294,748       1,100,342  

Cash at beginning of period

     3,277,602       2,365,082  
  

 

 

   

 

 

 

Cash at end of period

   $ 3,572,350     $ 3,485,424  
  

 

 

   

 

 

 

 

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