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): January 7, 2019

 

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 7.01                   Regulation FD Disclosure.

 

From January 7, 2019 to January 10, 2019, members of management of Dova Pharmaceuticals, Inc. (the “Company”), will hold meetings to review, among other things, the Company’s product candidate pipeline and outlook. A copy of the presentation that will accompany the meetings will be posted to the Company’s website, and is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) 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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01                   Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Company Presentation.

 

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: January 7, 2019

/s/ Mark W. Hahn

 

Mark W. Hahn

 

Chief Financial Officer

 

3


Exhibit 99.1

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J.P. Morgan 37th Annual Healthcare Conference January 8, 2019 David Zaccardelli, PharmD Chief Executive Officer

 

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Disclaimer Certain information contained in this presentation relates to or is based on studies, surveys and other data obtained from third-party sources and Dova’s own internal estimates and research. While Dova believes these sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. While Dova believes its internal research is reliable, such research has not been verified by any independent source. This presentation contains forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Dova’s current beliefs, expectations and assumptions regarding the future of Dova’s business, future plans and strategies, including the potential approval of DOPTELET for the treatment of adult patients with ITP who have had an insufficient response to a previous treatment and the potential to expand the treatment applications for DOPTELET. All statements other than statements of historical facts contained in this presentation, including statements regarding business strategy, degree of market acceptance of approved product, timing for commercial launch, timing and likelihood of success, and plans and objectives of management for future operations, are forward-looking statements. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements in this presentation represent Dova’s views as of the date of this presentation. Although Dova believes the expectations reflected in such forward-looking statements are reasonable, Dova can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, Dova does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. For further information regarding these risks, uncertainties and other factors, you should read the “Risk Factors” section of 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 filed with the SEC on November 8, 2018 and Dova’s other Periodic Reports filed with the SEC. 2

 

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New Team Members • David Zaccardelli, PharmD joins as President & CEO (12/17/18) • Jason Hoitt joins as Chief Commercial Officer (12/17/18) Viread HBV EXONDYS 51 ARIKAYCE Incivek 3

 

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Key Business Highlights At-A-Glance thrombocytopenia (i.e., low platelet counts) liver disease (CLD) scheduled to undergo a procedure Thrombocytopenia (ITP) with a target PDUFA date of June 30, 2019 4  $122.0M cash and equivalents on hand (as of September 30, 2018)  $12.6M used to fund clinical and commercial operations for Q3, 2018  $20M long-term debt FINANCIALS  Supplemental NDA accepted for review by the FDA for the treatment of Chronic Immune  Well differentiated vs Promacta® (eltrombopag), Nplate® (romiplostim) and TavalisseTM (fostamatinib)  Chemotherapy Induced Thrombocytopenia (CIT) study remains on track for 1H 2020 PIPELINE  DOPTELET approved May 21, 2018 for the treatment of thrombocytopenia in adult patients with chronic  DOPTELET launched in June 2018  Partnership with Salix positions DOPTELET for significantly increased market presence in 2019 LAUNCH  DOPTELET®, a second generation thrombopoietin receptor agonist used in the treatment of  DOPTELET has demonstrated robust efficacy in both the acute and the chronic setting  Patent until May 2025; pending patent term ext. app. to extend patent until 10/2029 DOPTELET®

 

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May 21st, 2018: DOPTELET Receives FDA Approval DOPTELET (avatrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET. Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency). DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts. CONTRAINDICATIONS: None ADVERSE REACTIONS Most common adverse reactions ( 3%) are: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral. Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com 5

 

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Initial Observations on Opportunities, Improvements and Next Steps • Gained substantial insight into the CLD market • ITP Large Commercial Opportunity – Established/well-defined market: $800M U.S. ($1.5B globally) – Target PDUFA date for ITP sNDA (6/30/19) • CIT offers notable, differentiated market opportunity • Key near-term objectives: – – – Improve CLD commercial performance ITP approval/launch readiness Complete CIT clinical trial by 1H 2020 6

 

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Significant Upside Potential for DOPTELET in CLD • • Comprehensive commercial review underway Unmet medical need for DOPTELET – – – – Sales force alignment/deployment Customer call strategy/Salix alignment Marketing Market access, pricing strategy • Shift in physician mindset/treatment paradigm • Requires change in practice/behavior – – Lead-time to procedure Platelet transfusion  tablet administration New treatment paradigm for payors • Salix partnership has potential to provide significant launch momentum – 7

 

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Market Segmentation Practices 8 Low Potential Medium Potential High Potential Academic Setting Academic Cent w/o LTC ersLiver Transplant Centers (LTC) Community Setting Small Independent GI Practices Large Gastro. Group

 

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DOPTELET: Potential to Address Various Types of Thrombocytopenia PRECLINICAL PHASE 1 PHASE 2 PHASE 3 COMMERCIAL STATUS CLD (Chronic Liver Disease) APPROVED (U.S.) MAA Submitted ITP (Chronic Immune Thrombocytopenia) sNDA Accepted for review by FDA Target PDUFA Date: 6/30/19 CIT (Chemotherapy-Induced Thrombocytopenia) Target Completion Date: 1H 2020 9

 

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DOPTELET: A Differentiated Therapy for a Large Market--Chronic ITP • Approved therapies have established annual cITP market $800 million (U.S.)/$1.5 billion (global) at • Well-established treatment paradigm for TPO agonists • DOPTELET effective and well tolerated in clinical trials • Differentiated/preferred profile 10

 

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DOPTELET Efficacy and Safety Data in Patients with ITP • Pivotal Efficacy Data from Phase 3 Study 302 (n=49) – Primary endpoint: cumulative number of weeks of platelet response – avatrombopag superior relative to placebo (p<0.0001) 1st secondary efficacy endpoint: superior platelet response at day 8 relative to placebo (p<0.0001) Positive trend favoring avatrombopag for 2nd secondary endpoint, proportion of subjects with a reduction in use of concomitant ITP medications from baseline – – • Primary Safety Data from studies of avatrombopag in patients with ITP – – – 128 patients with ITP treated with avatrombopag Median duration of exposure 204 days, with 63% treated for at least 180 days Exposure-adjusted adverse event rates comparable to placebo No data clinically significant hepatotoxicity or increased incidence of thromboembolic or • bleeding events 11 Jurczak W, et al. Br J Haematol. 2018. Published Online, https://doi.org/10.1111/bjh.15573 Internal Company data and analysis on file

 

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DOPTELET Phase 3 ITP Efficacy Data: Median Platelet Count Over Time Avatrombopag maintained the target platelet count (50 to <150×109/L) over the 6-month treatment period 200 180 160 140 120 100 80 60 40 20 0 Target Range: 50-150 x 109/L 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Study Visit Time (in weeks related to Randomization day) 24 25 26 Avatrombopag Placebo Jurczak W, et al. Br J Haematol. 2018. Published Online, https://doi.org/10.1111/bjh.15573 12 Platelet Count (x 109 / L) Titration Concomitant ITP Med Reduction Maintenance

 

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If Approved by FDA, we Believe DOPTELET is Well-Differentiated HEPATOTOXICITY DOSING FOOD EFFECT NO HEPATOTOXICTY ONCE DAILY ORAL DOSING CONVENIENT ADMINISTRATION WITH FOOD “PROMACTA MAY INCREASE THE RISK OF SEVERE AND POTENTIALLY LIFE-THREATENING HEPATOTOXICITY” TAKE ON AN EMPTY STOMACH (1 HOUR BEFORE OR 2 HOURS AFTER) ONCE DAILY ORAL DOSING NO HEPATOTOXICTY SUBCUTANEOUS N/A ELEVATED LIVER FUNCTION TESTS CAN OCCUR “MONITOR LIVER FUNCTION TESTS MONTHLY DURING TREATMENT”. TWICE DAILY ORAL DOSING MAY BE TAKEN WITH OR WITHOUT FOOD Note: DOPTELET’s currently approved indication is the treatment of thrombocytopenia in adult patients with chronic liver disease scheduled to undergo a procedure; Promacta’s indication is chronic ITP, pediatric chronic ITP, severe aplastic anemia and chronic hepatitis C; Nplate’s indication is chronic ITP, Tavalisse’s indication is chronic ITP DOPTELET has not yet been approved by the FDA for the treatment of chronic ITP. This represents data from the studies completed to date 13

 

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DOPTELET: Potential to Address Various Types of Thrombocytopenia PRECLINICAL PHASE 1 PHASE 2 PHASE 3 COMMERCIAL STATUS CLD (Chronic Liver Disease) APPROVED (U.S.) MAA Submitted ITP (Chronic Immune Thrombocytopenia) sNDA Accepted for review by FDA Target PDUFA Date: 6/30/19 CIT (Chemotherapy-Induced Thrombocytopenia) Target Completion Date: 1H 2020 14

 

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Potential Fit for DOPTELET in CIT Standard of Care DOPTELET has the potential to address a significant unmet medical need for patients with CIT Chemotherapy Dose Reduction 1 Cycle Delay / Cancellation 2 Platelet Transfusion 3 4 15 * Zhang X, et al. Cochrane Database Syst Rev. 2017;11:CD02035. Hitron A, et al. J Oncol Pharm Prac 2011 Dec;17(4):312-9 Type of Cancer Regime Rate of TCP* NSCLC Platinum/Gemcitabine 50.5% Ovarian Platinum/Taxane 45.6% Bladder Platinum/Gemcitabine 57.0%

 

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Chemotherapy Induced Thrombocytopenia (CIT) Phase 3 Design STUDY DESIGN Phase 3 randomized, double-blind, placebo-controlled study of the efficacy and safety of oral avatrombopag in subjects with active non-hematological cancers (i.e., ovarian, NSCLC, bladder) who develop CIT (platelet count <50K / µL in the previous cycle of chemo) N = 120 (2:1 RDZ) CYCLE X +2 CYCLE X +1 16 PLACEBO PLACEBO PC < 50K DURING CYCLE X OF CHEMO 60MG AVA 60MG AVA STUDY DRUG NOT ADMINISTERED: OBSERVATION CYCLE ONLY TO DETERMINE OUTCOME OF PRIMARY ENDPOINT SCREENING TREATMENT DAY 1-5 CHEMO DAY TREATMENT DAY 1-5

 

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Global Rights + Significant Patent Life for DOPTELET • MAA pending for the treatment of adults patients with CLD who are scheduled to undergo a procedure - expected action date in Q3 2019 • EU + RoW partnership opportunities across indications provide opportunities for additional revenue + non-dilutive capital • Robust IP, including composition of matter through 2025 (U.S.) – Potential for patent term extension through 2029 – EU patent protection into 2032 17

 

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Near-term Revenue Growth Potential + Label Expansion in 1H 2019 ROBUST PIPELINE STRONG CASH POSITION EXPERIENCED NEW LEADERSHIP FAVORABLE IP • David Zaccardelli, PharmD • sNDA for ITP ($1.5 billion global market/$800 M U.S. market) accepted for review with a target PDUFA date of June 30, 2019 CIT Phase 3 study initiated in 2Q 2018, expected completion 1H 2020 • Composition of matter patents expire in 2025 with potential patent term extension to 2029 EU patent protection through August 2032 • $122.0 M cash and equivalents as of 9/30/18 $20 M long-term debt $12.6 M used to fund clinical and commercial operations for Q3 2018 joins as CEO (12/17/18) Jason Hoitt joins as CCO (12/17/18) Proven leaders with track records of development and commercial success Comprehensive commercial review underway • • • • • • • 18

 

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