— Announced Initiation of Funding from BARDA for All FDA Required Post-Marketing Studies and Security Requirements and U.S. Onshoring of an Additional Manufacturing Supply Chain for NUZYRABOSTON, May 11, 2020 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the quarter ended March 31, 2020. NUZYRA generated $7.3 million in net revenue in the first quarter of 2020.The Company transitioned efficiently to a fully virtual model including the sales and marketing organization.Over 80% of commercial lives, greater than 50% of Medicaid lives and over one third of Medicare lives in the U.S. now have access to NUZYRA with limited or no restrictions.Secured multi-year agreement with Humana Medicare Part D and Commercial lines of business to place NUZYRA on their formulary with no restrictions.Other Highlights
Biomedical Advanced Research and Development Authority (BARDA) has initiated funding to support all of the U.S. Food and Drug Administration (FDA) post-marketing requirements associated with the approval of NUZYRA including pneumonia and pediatric studies as well as the five-year post-marketing bacterial surveillance study.The cost reimbursement for these post-marketing commitments is projected to total approximately $77 million.BARDA initiated funding to support the onshoring of Paratek manufacturing activities for NUZYRA.The cost reimbursement for the onshoring and security requirement activities is projected to total approximately $20 million over the next couple of years.Helps to further secure NUZYRA’s overall supply chain, adding a comprehensive additional supply chain to our existing infrastructure, and over the projected collaboration timeframe, will provide for a secure, United States based manufacturing supply chain.The Company’s partner for the greater China region, Zai Lab Limited (Zai Lab), announced its New Drug Application (NDA) for omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) has been accepted with priority review in China. Paratek earned $3.0 million upon this regulatory submission in the fourth quarter of 2019. Paratek is eligible to receive $6.0 million upon regulatory approval and royalties on net sales.Data from the NUZYRA clinical and microbiology programs were made available through the 30th European Congress of Clinical Microbiology & Infectious Diseases, ECCMID 2020. Four abstracts from the congresses abstract book released last week continued to highlight the efficacy and safety profile of NUZYRA, highlighting omadacycline’s in vitro activity for a number of key pathogens, quality of life outcomes in the Phase 3 program and the epidemiology and potential advantages omadacycline with regards to Clostridioides difficile infections.Paratek granted a license to Almirall, S.A. (Almirall, BME ticker: ALM) for SEYSARA® (sarecycline) in the greater China region, which includes the Peoples Republic of China, Hong Kong, and Macau. Almirall plans to develop sarecycline for acne in China, with a submission to the China National Medical Products Administration expected in 2023. Under the terms of the agreement, Paratek will earn high single-digit royalties on net sales.
Anticipated Near-Term 2020 Milestones
The initial NUZYRA procurement by BARDA for the Strategic National Stockpile (SNS) valued at approximately $38 million remains on track and is anticipated to be secured in the second quarter of 2020.The supplemental NDA to support an oral-only dosing label for CABP is anticipated to be filed with the FDA mid-year with potential approval during the 2020-2021 pneumonia season. First Quarter 2020 Financial Results
Paratek reported a net loss of $27.6 million, or ($0.66) per share, for the first quarter of 2020, compared to a net loss of $35.6 million, or ($1.10) per share, for the same period in 2019. Paratek estimates 2020 total revenues to be between $75 and $80 million. This revenue consists of the following elements:2020 NUZYRA U.S. net product sales is expected to be approximately $66 million with approximately $38 million of these sales coming from the initial BARDA procurement of 2,500 anthrax treatment courses.The initial NUZYRA BARDA procurement is anticipated to be secured in the second quarter of 2020.Royalty and collaboration revenue combined with government contract service revenue earned under the BARDA contract are expected to be approximately $9 to $14 million.Of note, government contract service revenue consists of cost reimbursement by BARDA for 2020 spend on the Company’s post-marketing requirement clinical development activities, anthrax development program and onshoring of U.S. NUZYRA manufacturing.2020 R&D and SG&A expense is expected to be approximately $140 million.R&D expense includes approximately $5 million earmarked for start-up activities in preparation for potential nontuberculous mycobacteria (NTM) studies.Excluding the BARDA R&D and onshoring cost reimbursement, R&D and SG&A expense is expected to remain relatively flat when compared to 2019.Based upon the Company’s current operating plan, which includes estimated NUZYRA product sales, and the BARDA cost reimbursement of activities related to the Project BioShield contract, the Company anticipates that its existing cash, cash equivalents and marketable securities of $194.8 million as of March 31, 2020, provide for a cash runway through the end of 2023 with a pathway to cash flow break even. This anticipated pathway assumes the Company will be able to fund all company operating expenses, anticipated capital expenditures, and debt service, including repayment in full of the Hercules Loan and Security Agreement under its existing terms. Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance.
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