Dova Pharmaceuticals Reports First Quarter 2019 Operating and Financial Results
Dova Pharmaceuticals Reports First Quarter 2019 Operating and Financial Results
- First Quarter 2019 net product sales of
$4.0 millionfrom DOPTELET® (avatrombopag)
- New marketing campaign launched early in second quarter for the treatment of thrombocytopenia associated with chronic liver disease (CLD)
- sNDA under review by the U.S.
FDAfor DOPTELET for the treatment of chronic immune thrombocytopenia (ITP); PDUFA date June 30, 2019
- Positive opinion received from CHMP on the DOPTELET Marketing Authorization Application (MAA) for CLD indication;
European Commissiondecision expected third quarter of 2019
- Conference call scheduled for
9:00 a.m. ETtoday
“Since refining our commercial strategy in December, we have become increasingly confident in the potential opportunities for DOPTELET as a treatment for thrombocytopenia. We are also encouraged by the initial feedback on our revised marketing and sales activities, which we expect to drive DOPTELET sales,” said Dr.
DOPTELET Launch Highlights
- Net product sales for DOPTELET were
$4.0 millionfor the first quarter, an increase of 43% from the fourth quarter of 2018.
- The US sales team was restructured in early
January 2019. It is now comprised of 44 sales territories and 5 regional directors responsible for driving DOPTELET sales in the hepatology, hematology, and interventional radiology physician segments.
- Co-promotion partner, Salix, with approximately 100 sales representatives, is responsible for driving DOPTELET sales for gastroenterology, colorectal surgery and proctology practices, and continues to progress as an integrated approach to expand our prescriber base.
- Early in the second quarter, a new marketing strategy was launched, including revised product positioning, messaging, and a new action-oriented brand campaign.
- From launch through
March 31, 2019, a total of 1,060 health care professionals have prescribed DOPTELET to their patients, with an increasing number of repeat prescribers.
- More than 13,000 calls were conducted, reaching more than 6,500 unique health care providers during the first quarter of 2019.
- For prescriptions in the first quarter that have gone through the adjudication process with payers, 82% of those prescriptions were approved. On average, the time to decision for a referral was 6.3 business days in the quarter.
- Inventory held by specialty pharmacies in Dova’s contracted network remained relatively constant from
January 1, 2019to March 31, 2019.
Additional First Quarter Highlights
- DOPTELET sNDA – under review by the
U.S. Food and Drug Administration( FDA) for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The Prescription Drug User Fee Act (PDUFA) goal date for an FDAdecision is June 30, 2019. Sales professionals with hematology/oncology experience, with a focus on ITP, are being recruited to the sales force in anticipation of a potential U.S. launch.
- DOPTELET MAA – received a positive opinion from the
Committee for Medicinal Products for Human Use(CHMP) of the European Medicines Agency(EMA) for DOPTELET for the treatment of severe thrombocytopenia in adult patients with CLD who are scheduled to undergo an invasive procedure. A European Commissiondecision for the MAA is expected in the third quarter of 2019.
- Phase 3 CIT Clinical Trial – continues to enroll patients for the treatment of chemotherapy-induced thrombocytopenia (CIT); plan reporting of primary and select secondary results in the first half of 2020.
First Quarter Financial Results
Net product sales for DOPTELET were
Dova reported a net loss of
Cost of product sales for the first quarter were
Research and development expenses were
Selling, general and administrative expenses were
Company to Host Conference Call
Dova will host a conference call today,
To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 9551427 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.
Indication and Important Safety Information
DOPTELET (avatrombopag) is 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.
Most common adverse reactions (≥ 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.
Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com
About Dova Pharmaceuticals, Inc.
Dova is a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for diseases where there is a high unmet need, with an initial focus on addressing thrombocytopenia. Dova’s proprietary pipeline includes one commercial product, DOPTELET, for the treatment of thrombocytopenia in adult patients with chronic liver disease scheduled to undergo a procedure.
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 opportunities for DOPTELET, which include the potential approval by
Chief Financial Officer
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
|Dova Pharmaceuticals, Inc.|
|Consolidated Statements of Operations|
|(in thousands, except share and per share amounts)|
|Three Months Ended March 31,|
|Product sales, net||$||4,001||$||-|
|Total revenue, net||4,001||-|
|Cost of product sales (see Note A)||515||-|
|Research and development (see Note A)||4,084||3,416|
|Selling, general and administrative (see Note A)||15,754||10,261|
|Total operating expenses||20,353||13,677|
|Loss from operations||(16,352||)||(13,677||)|
|Other income, net||537||222|
|Total other expenses, net||(27||)||(93||)|
|Net loss per share, basic and diluted||$||(0.58||)||$||(0.52||)|
|Weighted average common shares outstanding, basic and diluted||28,221,346||26,589,192|
|Stock-based compensation expense included in:|
|Cost of product sales||$||30||$||-|
|Research and development||498||431|
|Selling, general and administrative||2,685||2,385|
|Total stock-based compensation||$||3,213||$||2,816|
Summary Balance Sheet Data
|March 31,||December 31,|
|Cash and equivalents||$||92,703||$||104,566|
|Debt/Note, short-term and long-term||$||20,841||$||20,608|
|Total stockholders' equity||$||63,292||$||76,358|
Source: Dova Pharmaceuticals, Inc.