On March 1, 2018 Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, reported financial results and provided an update on financial, clinical, and regulatory filing activities for the quarter and full year ended December 31, 2017 (Press release, Paratek Pharmaceuticals, MAR 1, 2018, View Source [SID1234524314]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We had a strong finish to the year as we initiated our Phase 2 program in urinary tract infections and, importantly, we recently announced the completion of the rolling NDA submissions for omadacycline," said Michael Bigham, Chairman and Chief Executive Officer, Paratek. "We continue to expand our commercial readiness activities for omadacycline as we await the FDA’s acceptance of our NDAs".
Recent Highlights
Completed submission of New Drug Applications (NDAs) with the U.S. Food and Drug Administration (FDA) on February 2, 2018 for the once-daily oral and intravenous formulations of omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI)
Advanced commercial readiness activities, including initiation of manufacturing validation and commercial product supply and expansion of the medical affairs and payer account management teams in readiness for payer formulary discussions
Initiated the first of two Phase 2 studies of omadacycline in urinary tract infections (UTI)
Announced FDA acceptance of Allergan’s NDA for Seysara
Raised $50.0 million through a registered underwritten public offering of common stock
Upcoming Milestones
FDA acceptance of omadacycline NDAs anticipated in April 2018
Formulary discussions with payers to begin post FDA acceptance of NDA filing
Presentation of clinical and microbiological data at the upcoming European Congress of Clinical Microbiology and Infectious Disease, including nine posters and one oral presentation of the OASIS-2 study of oral-only omadacycline in ABSSSI
European pre-submission meetings planned for the second quarter of 2018
Fourth Quarter and Full Year 2017 Financial Results
For the fourth quarter of 2017, Paratek reported a net loss of $21.9 million, or ($0.78) per share, compared to a net loss of $26.5 million, or ($1.16) per share, for the same period in 2016. For the year ended December 31, 2017, Paratek reported a net loss of $89.1 million, or ($3.32) per share, compared to a net loss of $111.6 million, or ($5.51) per share, for the same period in 2016.
Revenue earned during the year ended December 31, 2017 primarily consists of a $7.5 million upfront payment
received as part of a collaboration agreement with Zai Lab and a $5.0 million milestone payment earned from Allergan on FDA acceptance of the Seysara NDA.
Research and development expenses were $14.2 million and $60.1 million for the quarter and year ended December 31, 2017, respectively, compared to $19.7 million and $83.5 million for the same periods in 2016. The decrease was driven primarily by lower clinical study costs associated with the completion of the Phase 3 program for omadacycline. This decrease is partially offset by higher employee compensation costs, NDA preparation and related user fees, and an increase in medical affairs activity.
General and administrative expenses were $11.7 million and $37.0 million for the quarter and year ended December 31, 2017, respectively, compared to $6.5 million and $26.4 million for the same periods in 2016. The increase was driven primarily by higher employee compensation costs as the Company continues to expand its commercial team, costs associated with pre-commercial activities, and business development efforts.
As of December 31, 2017, Paratek had cash, cash equivalents, and marketable securities of $151.7 million. Based on current assumptions, including full commercial buildout and launch of omadacycline, Paratek’s existing capital resources as well as the $50 million in proceeds from its January 2018 public offering of common stock, future contingent regulatory and commercial milestone payments from collaborations with Allergan and Zai Lab, anticipated extension of the interest-only period for the Hercules Term Loan, and estimated omadacycline product sales will enable Paratek to fund operating expenses and capital expenditure requirements into late 2019.
Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended December 31, 2017 will be broadcast at 8:30 a.m. EDT on March 1, 2018. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek’s website at www.paratekpharma.com.
Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13675875. Investors can also access the call at View Source
Replays of the call will be available through March 15, 2018. Domestic investors can access the replay by dialing 844-512-2921 and international investors can access the replay by dialing 412-317-6671. The PIN code to access the replay is 13675875.
Website Information
Paratek routinely posts important information for investors on the Investor Relations section of its website at www.paratekpharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek’s website is not incorporated by reference into, and is not a part of, this document.