PRTK Paratek Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Omadacycline - oral
Acute bacterial skin and skin structure infections (ABSSSI)
|
sNDA Filing
sNDA Filing
|
sNDA filing submitted July 2020.
|
|
Omadacycline
Complicated urinary tract infections (cUTI) / acute pyelonephritis
|
Phase 2
Phase 2
|
Phase 2 data released October 31, 2019. Comparable levels of clinical success but microbiological responses were generally lower than comparators.
|
|
Omadacycline
Urinary tract infections
|
Phase 2
Phase 2
|
Phase 2 data released October 31, 2019. Comparable levels of clinical success but microbiological responses were generally lower than comparators.
|
|
Omadacycline
Acute bacterial skin and skin structure infections (ABSSSI)
|
Approved
Approved
|
FDA Approval announced October 2, 2018.
|
|
Omadacycline
Community-acquired bacterial pneumonia (CABP)
|
Approved
Approved
|
FDA Approval announced October 2, 2018.
|
|
Sarecycline
Severe acne vulgaris
|
Approved
Approved
|
FDA Approval announced October 2, 2018.
|
|
Intermezzo
Insomnia
|
Approved
Approved
|
Approved November 23, 2011.
|
Latest News
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BOSTON, Nov. 12, 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 announced that the Company will present at the 2020 Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 11:25 a.m. ET or 4:25 p.m. GMT.
To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/jeff141/paratek/2291400.
Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is 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.
The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a five-year contract from the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $285 million, with an option to extend to ten years, to support the development of NUZYRA for the treatment of pulmonary anthrax, FDA post-marketing requirements (PMR) associated with the initial NUZYRA approval, and the option to procure up to 10,000 treatment courses of NUZYRA for the Strategic National Stockpile (SNS) for use against potential biothreats.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.CONTACT:
Investor and Media Relations: Ben Strain 617-807-6688 [email protected] 
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-- NUZYRA® (omadacycline) Generated Net Product Revenue of $10.9 Million in the Third Quarter 2020; a 35% Increase Over the Prior Quarter
-- Paratek now Anticipates Full Year 2020 Total Revenue to be at the Higher End of the Previously Communicated Range of $78 to $83 Million
-- Company Lowering 2020 R&D and SG&A Expense Guidance to Approximately $120 million
-- Omadacycline Added to the FDA's Essential Medicines List as a Medical Counter Measure Against Biological ThreatsBOSTON, Nov. 05, 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 September 30, 2020.
"We continue to execute against our plan for NUZYRA, which is reflected in the third quarter net revenue growth of 35% over the prior quarter," said Evan Loh, M.D., Chief Executive Officer. "Our launch trajectory continues to show NUZYRA is meaningfully outperforming other recent antibiotic launches, which we believe reflects the clinical importance of NUZYRA's oral dosing flexibility. We are particularly pleased with this revenue growth despite an environment that saw a continued downturn in overall broad-spectrum antibiotic utilization of approximately 18% versus the same period in the prior year. NUZYRA is making a real difference in the lives of patients, and prescribers recognize that NUZYRA is an important life-saving antibiotic that addresses current and future needs in the face of the growing global threat from antibiotic resistance."
Third Quarter 2020 NUZYRA Commercial Highlights and Update- NUZYRA generated $10.9 million in net revenue in the third quarter of 2020, a 35% increase over the prior quarter and a 252% increase over the third quarter of 2019.
- NUZYRA revenue growth reflects continued commitment to strong execution and NUZYRA's attributes that address unmet needs in the marketplace despite the reductions in patient traffic to physician offices and institutions of approximately 25% compared to pre-COVID-19 levels. In today's COVID-19 environment, NUZYRA's ability to minimize hospital stays with the oral formulation is especially relevant for many prescribers and a potentially meaningful benefit for patients.
Other Recent Highlights
- The Food and Drug Administration (FDA) review of the pre-Emergency Use Authorization (pre-EUA) application, which was submitted in February, remains ongoing. As part of the ongoing review, the supplemental mouse pharmacokinetic data requested by FDA are in the final stages of publishing at BARDA and will be submitted to FDA imminently. Based on agency discussions, we believe FDA will complete their review in a timely fashion.
- Seven posters from the NUZYRA clinical and microbiology programs were presented at the IDWeek 2020 virtual meeting in October 2020.
° In a multicenter real-world study evaluating NUZYRA, the authors concluded that NUZYRA was effective and well-tolerated in this small sample for a variety of infections, including pulmonary M. abscessus (11 patients; average treatment duration 6.4 months) and MDR/XDR A. baumannii and Enterobacteriaceae (7 patients; average duration 14 days). These data continue to reinforce the importance of additional studies to expand these encouraging clinical findings.
° Additional data presented also highlighted that the substitution of NUZYRA in place of standard of care, such as quinolones, for the treatment of patients with Community-Acquired Bacterial Pneumonia (CABP), has the potential to reduce Clostridioides difficile infection and deliver cost savings in the acute care setting.Third Quarter 2020 Financial Results
Total revenue was $13.7 million for the third quarter of 2020, an increase of 47% versus the prior quarter and 251% versus the same quarter in the prior year.- U.S. NUZYRA net revenue of $10.9 million for the third quarter of 2020 grew 35% versus the prior quarter and 252% versus the same quarter in the prior year.
- Government contract service and grant revenue was $2.7 million for the third quarter of 2020 versus $0.9 million in the prior quarter. No revenue was generated from the BARDA contract in 2019.
Research and development (R&D) expenses were $6.7 million for the third quarter of 2020, compared to $8.4 million for same period in the prior year. The $1.7 million decrease is primarily the result of lower clinical study costs associated with completion of the Phase 2 UTI program in 2019, partially offset by an increase in costs incurred under the BARDA contract and third-party manufacturing scale-up costs.
Selling, general and administrative (SG&A) expenses were $20.9 million for the third quarter of 2020, compared to $23.6 million for the same period in the prior year. The $2.7 million decrease is primarily the result of lower personnel-related costs and a reduction in sales and marketing costs due to COVID-19.
Paratek reported a net loss of $20.9 million, or ($0.46) per share, for the third quarter of 2020, compared to a net loss of $32.6 million, or ($1.00) per share, for the same period in 2019.
Financial Guidance
Paratek now anticipates its full year 2020 total revenue to be at the higher end of the previously communicated range of $78 to $83 million driven by strong NUZYRA net revenue trends.- This revenue guidance assumes that the initial BARDA procurement of NUZYRA, valued at approximately $38 million, will occur by the end of 2020. The FDA review could be completed as early as the end of this year but may slip into the first quarter of 2021. The first procurement is expected soon after completion of the FDA review. Accordingly, revenue from the first procurement will be recognized as early as late 2020 or in the first quarter of 2021.
- 2020 R&D and SG&A expenses are now expected to be approximately $120 million compared to the prior guidance of $135 million, driven by a continued focus on operational efficiencies, and the timing of certain expenses driven by the COVID-19 pandemic, some of which will now occur in 2021.
- Based upon our current operating plan, which includes estimated NUZYRA U.S. product revenue, BARDA procurements of NUZYRA for the SNS, and cost reimbursement under the BARDA contract, we anticipate that our existing cash, cash equivalents and marketable securities of $149.5 million, as of September 30, 2020, will 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.
Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance.
Call and Webcast
Paratek's earnings conference call for the quarter ended September 30, 2020 will be broadcast at 4:30 p.m. EST on November 5, 2020. The live audio 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: 888-204-4368 and international investors should dial: 323-994-2093. The conference ID is 9510788. Investors can also access the call at http://public.viavid.com/index.php?id=142174.
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, U.S. Securities and Exchange Commission (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.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is 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.
The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the impact of the COVID-19 pandemic on our revenue projections, access to hospital institutions, supply chain and clinical trials, projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including the status of the FDA review of the pre-EUA application, the status of our supplemental mouse pharmacokinetic data to support the human dose recommendation, the timing and exercise of BARDA's procurement of NUZYRA for the SNS, BARDA exercising full contract line items, including for U.S. onshoring and PMR reimbursement, our anticipated cash runway, our operating expenses, our SEYSARA royalties and SEYSARA -backed loan funded on May 1, 2019, the strategy, execution and progression of our commercial launch of NUZYRA, our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, our plans to evaluate additional indications for NUZYRA, including NTM, and to work toward an oral-only indication in CABP, future governmental stockpiling opportunities, and our potential to further drive long-term value for all of our shareholders. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.PARATEK PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)September 30,
2020December 31,
2019Cash, cash equivalents and marketable securities $ 149,498 $ 215,379 Total assets 198,686 251,079 Working capital 172,103 219,154 Total current liabilities 22,899 24,200 Long-term debt, less current portion 250,631 260,728 Common stock and additional paid-in capital 702,805 671,537 Accumulated deficit (782,789 ) (711,258 ) Total stockholders' deficit (79,884 ) (39,647 ) Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except loss per share data)Three Months Ended
September 30,Nine Months Ended
September 30,2020 2019 2020 2019 Product revenue, net $ 10,895 $ 3,053 $ 26,330 $ 6,102 Government contract service revenue 785 — 1,560 — Government contract grant revenue 1,866 — 2,303 — Collaboration and royalty revenue 113 881 710 1,475 Net revenue $ 13,659 $ 3,934 $ 30,903 $ 7,577 Expenses: Cost of product revenue 2,017 958 5,724 1,731 Research and development 6,687 8,350 17,636 30,421 Selling, general and administrative 20,902 23,636 65,514 67,874 Total operating expenses 29,606 32,944 88,874 100,026 Loss from operations (15,947 ) (29,010 ) (57,971 ) (92,449 ) Other income and expenses: Interest income 280 992 1,347 2,873 Interest expense (5,178 ) (4,560 ) (14,974 ) (11,777 ) Other gains (losses), net (10 ) (36 ) 67 (72 ) Net loss $ (20,855 ) $ (32,614 ) $ (71,531 ) $ (101,425 ) Other comprehensive loss Unrealized gain (loss) on available-for-sale securities, net of tax (154 ) (68 ) 26 276 Comprehensive loss $ (21,009 ) $ (32,682 ) $ (71,505 ) $ (101,149 ) Basic and diluted net loss per common share $ (0.46 ) $ (1.00 ) $ (1.64 ) $ (3.12 ) Weighted average common stock outstanding Basic and diluted 45,483,346 32,590,454 43,591,724 32,458,010 CONTACT:
Investor and Media Relations: Ben Strain 617-807-6688 [email protected] -
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BOSTON, Oct. 21, 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, announced today that data from its NUZYRA (omadacycline) clinical and microbiology programs are being presented at the IDWeek 2020 virtual meeting.
NUZYRA is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.
Poster presentations are available beginning on Wednesday, October 21 in the IDWeek ePoster Gallery.
Presentation Title: Subinhibitory Concentrations of Omadacycline Inhibit Staphylococcus aureus Hemolytic Activity In Vitro
Poster #: 1202
Presenter: A. SerioPresentation Title: In Vitro Activity of Omadacycline Against 7000 Bacterial Pathogens from the United States Stratified by Infection Type (2019)
Poster #: 1253
Presenter: M. HubandPresentation Title: Comparative Activity of Omadacycline Against Extended-spectrum Beta-lactamase Positive and Negative Escherichia coli and Klebsiella pneumoniae Strains Recovered from Urine Specimens
Poster #: 1267
Presenter: T. StonePresentation Title: Real-World Experience with Omadacycline for Nontuberculous Mycobacterial and Gram-Negative Infections: A Multicenter Evaluation
Poster #: 1290
Presenter: T. MorrisettePresentation Title: Targeted Substitution of Omadacycline in Place of Standard of Care for CABP Treatment is Associated with a Risk Reduction of Clostridioides difficile Infection and Financial Cost Savings in the Acute Care Setting
Poster #: 1492
Presenter: M. RodriguezPresentation Title: Omadacycline in Female Adults with Acute Pyelonephritis: Results from a Randomized, Double-Blind, Adaptive Phase 2 Study
Poster #: 1687
Presenter: K. WrightPresentation Title: Omadacycline in Female Adults with Cystitis: Results from a Randomized, Double-Blinded, Adaptive Phase 2 Study
Poster #: 1688
Presenter: K. Wright"These poster presentations continue our commitment to share new data about the clinical safety and efficacy of NUZYRA and ensure clinicians have comprehensive information available to them as they make treatment decisions for their patients with community-acquired infections," said Randy Brenner, Chief Development & Regulatory Officer of Paratek. "To that end, Paratek supports analysis of real-world use of NUZYRA, including the potential utility of NUZYRA in nontuberculous mycobacterium abscessus lung infections, a rare, chronic and difficult-to-treat lung infection for which there are currently no FDA approved therapies."
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is 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.The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
About NUZYRA
NUZYRA® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.
Indications and Usage
NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.Important Safety Information
Contraindications
NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.Warnings and Precautions
Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.
The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.
Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.
Drug Interactions
Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.
Use in Specific Populations
Lactation: Breastfeeding is not recommended during treatment with NUZYRA.
To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.CONTACTS:
Investor and Media Relations:
Ben Strain
617-807-6688
[email protected] -
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BOSTON, Sept. 09, 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 announced that the Company will present at H.C. Wainwright 22nd Annual Global Investment Conference, Monday, September 14, 2020 at 5:00 p.m. ET.
To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/hcw7/prtk/1629433.
Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is 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.The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.CONTACT:
Investor and Media Relations: Ben Strain 617-807-6688 [email protected] -
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-- Paratek Raises Full Year 2020 Revenue Guidance; Total Revenue guidance expected to be Between $78 and $83 Million Driven by Strong NUZYRA Net Revenue
-- Company Lowering 2020 R&D and SG&A Expense Guidance to approximately $135 million Driven by Continued Focus on Operational Efficiencies
-- FDA Pre-EUA Review Remains Ongoing; NUZYRA Procurement by BARDA for the Strategic National Stockpile Anticipated by year-end 2020
-- Company Strengthens Long-term Cash Position through Amendment to Hercules Loan Agreement
BOSTON, Aug. 10, 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 June 30, 2020.
"Demand for NUZYRA was strong in the first half of 2020 with the momentum continuing into the third quarter," said Evan Loh, M.D., Chief Executive Officer. "I am particularly pleased that these results were achieved despite a healthcare environment where the unprecedented global pandemic temporarily closed many healthcare practices and eliminated essentially all face to face access for our sales representatives. Our results reinforce our continued belief and confidence that NUZYRA is well-positioned to help address current and future unmet medical needs at a time when antibiotic resistance is a growing global threat."
"BARDA and Paratek continue to effectively execute on the anthrax development program and U.S. onshoring activities for NUZYRA," Dr. Loh continued. "The FDA review of the pre-EUA application remains ongoing and BARDA continues to be fully committed to procuring NUZYRA for the Strategic National Stockpile once the FDA review process is completed. We appreciate BARDA's confidence in Paratek and their significant investment in this innovative, long-term public-private partnership for the development of NUZYRA in the fight against bioterrorism and antimicrobial resistance in order to save lives and protect Americans."
Recent NUZYRA Commercial Highlights
- NUZYRA generated $8.1 million in net revenue in the second quarter of 2020, an 11% increase over the prior quarter and 378% increase over the second quarter of 2019. NUZYRA revenue growth continues to validate the Company's initial launch strategy with 90% of demand being generated from hospitals and adjacent sites of care.
Other Highlights
- The initial NUZYRA procurement by Biomedical Advanced Research and Development Authority (BARDA) for the Strategic National Stockpile (SNS) valued at approximately $38 million is now anticipated to be secured by year end 2020.
° The Food and Drug Administration (FDA) review of the pre-Emergency Use Authorization (pre-EUA) application, which was submitted in February, remains ongoing. The Company believes the review was delayed due to internal resourcing at FDA caused by the COVID-19 pandemic and other review priorities at FDA unrelated to NUZYRA. As part of the ongoing review, FDA has requested supplemental mouse pharmacokinetic data to support the human dose recommendation in case of an immediate anthrax outbreak. This work has been initiated and expected to be completed in 8 to 10 weeks.
- In July 2020, the supplemental NDA to support an oral-only dosing label for Community-Acquired Bacterial Pneumonia (CABP) was submitted to FDA with an approval expected during the 2020-2021 pneumonia season.
- In August 2020, Paratek modified its outstanding loan agreement with Hercules Capital.
° Under the terms of the agreement, Paratek repaid $10 million of the principal $70 million loan balance reducing the outstanding loan to $60 million.
° The interest-only period under the new loan agreement is now extended through December 2021, with further extension of the interest-only period of up to an additional 12 months, contingent on Paratek achieving certain performance-based milestones.Second Quarter 2020 Financial Results
Paratek reported a net loss of $23.1 million, or ($0.53) per share, for the second quarter of 2020, compared to a net loss of $33.2 million, or ($1.02) per share, for the same period in 2019.Total revenue was $9.3 million for the second quarter of 2020, an increase of 18% versus the prior quarter and 356% versus the same quarter in the prior year.
- U.S. NUZYRA net revenue of $8.1 million for the second quarter of 2020 grew 11% versus the prior quarter and 378% versus the same quarter in the prior year.
- Government contract service and grant revenue was $0.9 million for the second quarter of 2020 versus $0.3 million in the prior quarter. No revenue was generated from the BARDA contract in 2019.
- Second quarter 2020 collaboration and royalty revenue was $0.3 million, which is consistent with both the prior quarter and the same quarter in prior year.
Research and development (R&D) expenses were $4.6 million for the second quarter of 2020, compared to $10.7 million for the second quarter of 2019. The $6.1 million decrease is primarily the result of lower personnel-related costs, lower clinical study costs associated with our Phase 2 UTI program and other operational efficiencies.
Selling, general and administrative (SG&A) expenses were $21.0 million for the second quarter of 2020, compared to $20.9 million for the second quarter of 2019.
As of June 30, 2020, Paratek had $186.8 million in cash, cash equivalents and marketable securities.
Financial Guidance
Paratek is raising its full year 2020 revenue guidance primarily based on the stronger than anticipated U.S. NUZYRA net product revenue modestly offset by lower than anticipated royalty revenue from SEYSARA.- Paratek now estimates 2020 total revenue to be between $78 and $83 million, an increase from our prior guidance of $75 and $80 million.
° The Company now anticipates the initial BARDA procurement of 2,500 anthrax treatment courses valued at approximately $38 million to occur by the end of 2020 contingent on the completion of the pre-EUA application review by FDA.
- 2020 R&D and SG&A expense is now expected to be approximately $135 million compared to the prior guidance of $140 million, driven by an increased focus on operational efficiencies and other favorability driven by the COVID-19 pandemic. Excluding the BARDA R&D and onshoring cost reimbursement, R&D and SG&A expense is expected to be modestly lower when compared to 2019.
° Based upon our current operating plan, which includes estimated NUZYRA U.S. product revenue and cost reimbursement under the BARDA contract, we anticipate that our existing cash, cash equivalents and marketable securities of $186.8 million, as of June 30, 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.
Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance.
Call and Webcast
Paratek's earnings conference call for the quarter ended June 30, 2020 will be broadcast at 8:30 a.m. EDT on August 10, 2020. 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: 888-256-1007 and international investors should dial: 323-994-2093. The conference ID is 8856661. Investors can also access the call at http://public.viavid.com/index.php?id=141013.
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, U.S. Securities and Exchange Commission (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.About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is 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.The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the impact of the COVID-19 pandemic on our revenue projections, supply chain and clinical trials, projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including the status of the FDA review of the pre-EUA application, the status of our supplemental mouse pharmacokinetic data to support the human dose recommendation, the timing and exercise of BARDA's procurement of NUZYRA for the SNS, BARDA exercising full contract line items, including for U.S. onshoring and PMR reimbursement, our anticipated cash runway, our operating expenses, our SEYSARA royalties and SEYSARA -backed loan funded on May 1, 2019, the strategy, execution and progression of our commercial launch of NUZYRA, our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, our plans to evaluate additional indications for NUZYRA, including NTM, and to work toward an oral-only indication in CABP, future governmental stockpiling opportunities, and our potential to further drive long-term value for all of our shareholders. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.PARATEK PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)June 30,
2020December 31,
2019Cash, cash equivalents and marketable securities $ 186,818 $ 215,379 Total assets 227,126 251,079 Working capital 188,278 219,154 Total current liabilities 33,925 24,200 Long-term debt, less current portion 251,586 260,728 Common stock and additional paid-in capital 698,222 671,537 Accumulated deficit (761,934 ) (711,258 ) Total stockholders' deficit (63,458 ) (39,647 ) Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except loss per share data)Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Product revenue, net $ 8,133 $ 1,702 $ 15,436 $ 3,049 Government contract service revenue 439 — 775 — Government contract grant revenue 437 — 437 — Collaboration and royalty revenue 317 343 597 594 Net revenue $ 9,326 $ 2,045 $ 17,245 $ 3,643 Expenses: Cost of product revenue 2,236 567 3,707 773 Research and development 4,561 10,679 10,949 22,071 Selling, general and administrative 20,975 20,920 44,613 44,238 Total operating expenses 27,772 32,166 59,269 67,082 Loss from operations (18,446 ) (30,121 ) (42,024 ) (63,439 ) Other income and expenses: Interest income 363 935 1,067 1,881 Interest expense (4,971 ) (3,991 ) (9,797 ) (7,217 ) Other gains (losses), net (5 ) (24 ) 78 (36 ) Net loss $ (23,059 ) $ (33,201 ) $ (50,676 ) $ (68,811 ) Other comprehensive loss Unrealized gain (loss) on available-for-sale securities, net of tax (217 ) 144 180 344 Comprehensive loss $ (23,276 ) $ (33,057 ) $ (50,496 ) $ (68,467 ) Basic and diluted net loss per common share $ (0.53 ) $ (1.02 ) $ (1.19 ) $ (2.12 ) Weighted average common stock outstanding Basic and diluted 43,629,836 32,446,202 42,635,520 32,390,691 Investor and Media Relations:
Ben Strain
617-807-6688
[email protected] - NUZYRA generated $8.1 million in net revenue in the second quarter of 2020, an 11% increase over the prior quarter and 378% increase over the second quarter of 2019. NUZYRA revenue growth continues to validate the Company's initial launch strategy with 90% of demand being generated from hospitals and adjacent sites of care.