UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 9, 2018

 

Dova Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware
(State or Other Jurisdiction
of Incorporation)

 

001-38135
(Commission
File Number)

 

81-3858961
(IRS Employer
Identification No.)

 

240 Leigh Farm Road, Suite 245
Durham, North Carolina

(Address of Principal Executive Offices)

 

27707
(Zip Code)

 

Registrant’s telephone number, including area code: (919) 748-5975

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x

 

 

 



 

Item 2.02  Results of Operations and Financial Condition.

 

On May 9, 2018, Dova Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2018, as well as information regarding a conference call to discuss these financial results and the Company’s recent corporate highlights and outlook. This press release has been furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

 

 

Number

 

Exhibit Description

99.1

 

Press Release, dated May 9, 2018

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Dova Pharmaceuticals, Inc.

 

 

 

 

Date: May 9, 2018

/s/ Mark W. Hahn

 

Mark W. Hahn

 

Chief Financial Officer

 

3


Exhibit 99.1

 

 

Dova Pharmaceuticals Reports First Quarter 2018 Operating and Financial Results

 

PDUFA date for avatrombopag of May 21, 2018

 

Conference call scheduled for 4:30 p.m. ET today

 

DURHAM, NC, May 9, 2018 — Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, today reported its operating and financial results for the first quarter ended March 31, 2018.

 

First Quarter and Recent Highlights

 

·                  Continued build-out of commercial infrastructure in preparation of the anticipated U.S. launch in June of avatrombopag for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. A New Drug Application (NDA) for avatrombopag was accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA) in November 2017. The Prescription Drug User Fee Act (PDUFA) goal date is May 21, 2018.

 

·                  Completed an underwritten public offering of 2,500,000 shares of common stock at an offering price of $32.00 per share. Net proceeds from the offering were approximately $74.7 million, after deducting underwriting discounts and commissions and other estimated offering expenses.

 

·                  Entered into an exclusive distribution agreement granting Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., (Fosun Pharma Industrial), a wholly owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA: 600196 and HKG: 02196), the exclusive development and distribution rights of avatrombopag for CLD patients with thrombocytopenia in mainland China and Hong Kong. Fosun will also support the development of avatrombopag for expanded indications in these markets.

 

·                  Began enrollment in a clinical trial in a broader population of adult patients with thrombocytopenia regardless of disease etiology undergoing surgery.

 



 

·                  Plan to submit a sNDA in the second half of 2018 for the treatment of patients with immune thrombocytopenic purpura (ITP) and to initiate a Phase 3 clinical trial in the second quarter of 2018 for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT).

 

·                  On April 27th, filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for avatrombopag for the treatment of thrombocytopenia in adult patients with CLD.  The EMA has granted a Standard Review Assessment for this MAA.

 

·                  Repaid, in full, the secured promissory note that was issued to Eisai on March 31, 2016 of $31.1 million.  The issuance of the note enabled the Company to finance payments due to Eisai under its transition services agreement for all costs incurred through December 31, 2017.

 

·                  Refinanced a portion of the Eisai note by entering into a Loan and Security Agreement with Silicon Valley Bank (SVB) for $20.0 million on April 17, 2018.  The loan matures on April 17, 2021 unless a specified revenue milestone is achieved in which case the maturity date will be extended to April 17, 2022.

 

·                  Appointed Mark W. Hahn as the company’s Chief Financial Officer.

 

“The highlight of the first quarter was the continued build-out of our commercial infrastructure as we progress towards a near-term potential U.S. launch of avatrombopag for the treatment of thrombocytopenia in patients with CLD. As we await our PDUFA date of May 21, 2018, we are now focused on preparing for a June launch,” said Alex C. Sapir, President and Chief Executive Officer of Dova. “In addition, Dova strengthened its cash position in the quarter, which further prepares us for launch and allows us to continue our development work in additional thrombocytopenia indications.”

 

First Quarter and Financial Results

 

Dova reported a net loss of $13.8 million for the first quarter of 2018, compared to a net loss of $5.4 million for the same period in 2017.

 

Research and development expenses were $3.4 million in the first quarter of 2018, compared to $4.3 million for the same period in 2017. The decrease was primarily due to the completion of the ADAPT-1 and ADAPT-2 Phase 3 clinical trials in January 2017, partially offset by the initiation of a Phase 3 clinical trial to evaluate avatrombopag in a broader population of patients with thrombocytopenia undergoing surgery regardless of disease etiology.

 

General and administrative expenses were $10.3 million in the first quarter of 2018, compared to $1.0 million for the same period in 2017. The increase was primarily due to building Dova’s commercial infrastructure to support the potential launch of avatrombopag, increased corporate infrastructure, and additional costs associated with operating as a public company.

 



 

As of March 31, 2018, Dova had $126.9 million in cash and cash equivalents compared to $94.8 million as of December 31, 2017. The increase was primarily due to the completion of an underwritten public offering which closed in February 2018, partially offset by the repayment of the Eisai note of $31.1 million and operating expenses.

 

Company to Host Conference Call

 

Dova will host a conference call today, May 9, 2018 at 4:30 p.m. ET to discuss first quarter 2018 financial results and recent operational highlights. A question-and-answer session will follow Dova’s remarks.

 

To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 7691889 five to 10 minutes before the start of the call.

 

A live audio webcast of the call will also be available via the “Investor Relations” page of the Dova website, www.dova.com. Please log on through Dova’s website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Dova’s website for 90 days following the call.

 

About Dova Pharmaceuticals, Inc.

 

Dova is a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, with an initial focus on addressing thrombocytopenia. Dova’s lead drug candidate, avatrombopag, has successfully completed two pivotal Phase 3 clinical trials for the treatment of thrombocytopenia in patients with CLD scheduled to undergo a procedure and an NDA has been accepted for priority review by FDA for this initial indication with a PDUFA goal date of May 21, 2018.

 

Cautionary Notes Regarding Forward-Looking Statements

 

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipated”, “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Dova’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential regulatory approval and commercial launch of avatrombopag for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure, as well as the development of avatrombopag for additional thrombocytopenia indications.  These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, increased regulatory requirements, Dova’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Dova’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission (SEC) on February 16, 2018, Dova’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, and Dova’s other periodic reports filed with the SEC. Any forward-looking statements speak

 



 

only as of the date of this press release and are based on information available to Dova as of the date of this release, and Dova assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

###

 

Contacts

 

Mark W. Hahn
Chief Financial Officer

 

(919) 338-7936
mhahn@dova.com

 

Westwicke Partners

John Woolford

(443) 213-0506

john.woolford@westwicke.com

 



 

Dova Pharmaceuticals, Inc.

 

Condensed Consolidated Statements of Operations

 

(In thousands, except share and per share amounts)

 

 

 

(Unaudited)

 

 

 

Three Months Ended

 

 

 

March 31, 2018

 

March 31, 2017

 

Operating expenses:

 

 

 

 

 

Research and development

 

$

3,416

 

$

4,276

 

General and administrative

 

10,261

 

955

 

Total operating expenses

 

13,677

 

5,231

 

Loss from operations

 

(13,677

)

(5,231

)

 

 

 

 

 

 

Total other expenses, net

 

(93

)

(193

)

Net loss

 

$

(13,770

)

$

(5,424

)

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.52

)

$

(0.31

)

 

 

 

 

 

 

Weighted average common shares outstanding, basic and diluted

 

26,589,192

 

17,332,257

 

 

Summary Balance Sheet Data

 

(in thousands)

 

 

 

March 31,

 

December 31,

 

 

 

2018

 

2017

 

 

 

(Unaudited)

 

 

 

Cash and equivalents

 

$

126,897

 

$

94,846

 

Total assets

 

$

128,750

 

$

96,379

 

Note payable, short-term and long-term, respectively

 

$

 

$

30,212

 

Total liabilities

 

$

3,648

 

$

35,197

 

Total stockholders’ equity

 

$

125,102

 

$

61,182