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PLX Protalix BioTherapeutics

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally–delivered anti-inflammatory treatment; alidornase alfa or PRX-110, for the treatment of various human respiratory diseases or conditions; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa, and with SarcoMed USA, Inc. for the worldwide development and commercialization of PRX–110 for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery.

Company profile

Ticker
PLX
Exchange
CEO
Dror Bashan
Employees
Incorporated
Location
Fiscal year end
Former names
EMBASSY ACQUISITION CORP, ORTHODONTIX INC
SEC CIK
IRS number
650643773

PLX stock data

(
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Calendar

14 May 21
27 Jul 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 19.83M 19.83M 19.83M 19.83M 19.83M 19.83M
Cash burn (monthly) (positive/no burn) (positive/no burn) 1.24M 474K 3.28M 2.4M
Cash used (since last report) n/a n/a 4.79M 1.84M 12.73M 9.33M
Cash remaining n/a n/a 15.04M 17.99M 7.1M 10.5M
Runway (months of cash) n/a n/a 12.2 38.0 2.2 4.4

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
3 Jun 21 Dexcel Pharma Technologies Common Stock Sell Dispose S No No 2.2534 857,506 1.93M 3,637,314
2 Jun 21 Dexcel Pharma Technologies Common Stock Sell Dispose S No No 2.5576 61,211 156.55K 4,494,820
11 Aug 20 Yaron Naos Stock Options Common Stock Grant Aquire A No No 3.59 122,656 440.34K 122,656
11 Aug 20 Eyal Rubin Common Stock Grant Aquire A Yes No 0 246,146 0 246,146
11 Aug 20 Dror Bashan Common Stock Grant Aquire A Yes No 0 447,927 0 447,927

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

36.9% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 39 25 +56.0%
Opened positions 19 7 +171.4%
Closed positions 5 10 -50.0%
Increased positions 10 2 +400.0%
Reduced positions 3 5 -40.0%
13F shares
Current Prev Q Change
Total value 2.06B 592.6M +247.9%
Total shares 16.76M 13.54M +23.8%
Total puts 233.8K 76.5K +205.6%
Total calls 175.2K 48.9K +258.3%
Total put/call ratio 1.3 1.6 -14.7%
Largest owners
Shares Value Change
Dexcel Pharma Technologies 4.56M $22.33M NEW
Nacht Marius 3.39M $12.3M 0.0%
Psagot Investment House 3.1M $13.81M +558.3%
Burrage Capital Management 2.13M $9.48M -14.0%
DAFNA Capital Management 1.2M $5.37M NEW
Renaissance Technologies 507.63K $2.26M +3.9%
Ubs Oconnor 445.17K $1.99B +196.8%
Bridgeway Capital Management 302.59K $1.35M +42.3%
PXGPE Phoenix 244.11K $1.09M NEW
Susquehanna International 203.81K $909K +266.6%
Largest transactions
Shares Bought/sold Change
Highbridge Capital Management 0 -6.06M EXIT
Dexcel Pharma Technologies 4.56M +4.56M NEW
Psagot Investment House 3.1M +2.63M +558.3%
DAFNA Capital Management 1.2M +1.2M NEW
Burrage Capital Management 2.13M -344.75K -14.0%
Ubs Oconnor 445.17K +295.17K +196.8%
PXGPE Phoenix 244.11K +244.11K NEW
Susquehanna International 203.81K +148.22K +266.6%
D.a. Davidson & Co. 130.7K +130.7K NEW
Advisor 122.18K +122.18K NEW

Financial report summary

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Risks
  • Item 1A. Risk Factors
  • We are subject to extensive governmental regulation including the requirements of the FDA and other comparable regulatory authorities before our drug candidates may be marketed.
  • We may find it difficult to enroll patients in our clinical trials, or patients may discontinue their participation in our clinical trials, which could cause significant delays in the completion of such trials or may negatively impact the results of these studies and extend the timeline for completion of our development programs or cause us to abandon one or more clinical trials.
  • If the results of our clinical trials do not support our claims relating to a drug candidate, or if serious side effects are identified, the completion of development of such drug candidate may be significantly delayed or we may be forced to abandon development altogether, which will significantly impair our ability to generate product revenues.
  • We have only limited experience in regulatory affairs, and some of our drug candidates may be based on new technologies. These factors may affect our ability or the time we require to obtain necessary regulatory approvals.
  • Orphan drug designation may not ensure that we will enjoy market exclusivity in any jurisdiction. If any of our other competitors are able to obtain orphan drug exclusivity for any products that are competitive with our products, we may be precluded from selling or obtaining approval of our competing products by the applicable regulatory authorities for a significant period of time.
  • The fast track designation for pegunigalsidase alfa for the treatment of Fabry disease may not lead to a faster development or regulatory review or approval process or increase the likelihood that pegunigalsidase alfa will receive regulatory approval for the treatment of Fabry disease.
  • Risks Related to Our Business
  • We have a limited operating history which may limit the ability of investors to make an informed investment decision.
  • We currently depend heavily on the success of pegunigalsidase alfa. Any failure to commercialize pegunigalsidase alfa, or the experience of significant delays in doing so, will have a material adverse effect on our business, results of operations and financial condition.
  • Any failure by us to supply drug substance to Pfizer may have a material adverse effect on our business, results of operations and financial condition.
  • Our strategy, in certain cases, is to enter into collaboration agreements with third parties to leverage our ProCellEx system to develop product candidates. Failure to enter into such agreements, or non-compliance by us or our collaborators with such agreements, may have a material adverse effect on our business, results of operations and financial condition.
  • If we are unable to develop and commercialize our product candidates, our business will be adversely affected.
  • The manufacture of our products is an exacting and complex process, and any manufacturing problems encountered by us or certain of our suppliers may have a material adverse effect on our business, results of operations and financial condition.
  • We rely on third parties for final processing of taliglucerase alfa, pegunigalsidase alfa and our other product candidates, which exposes us to a number of risks that may delay development, regulatory approval and commercialization of taliglucerase alfa and our other product candidates or result in higher product costs.
  • Developments by competitors may render our products or technologies obsolete or non-competitive which would have a material adverse effect on our business, results of operations and financial condition.
  • If we in-license drug candidates, we may delay or otherwise adversely affect the development of our existing drug candidates, which may negatively impact our business, results of operations and financial condition.
  • If we are unable to manage future growth successfully there could be a material adverse impact on our business, results of operations and financial condition.
  • If we acquire companies, products or technologies, we may face integration risks and costs associated with those acquisitions that could negatively impact our business, results of operations and financial condition.
  • We depend upon key employees and consultants in a competitive market for skilled personnel. If we are unable to attract and retain key personnel, it could adversely affect our ability to develop and market our products.
  • Our collaborations with outside scientists and consultants may be subject to restriction and change.
  • Under current U.S. and Israeli law, we may not be able to enforce employees’ covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
  • Our internal computer systems, or those used by our third-party contractors or consultants, may fail or suffer security breaches.
  • If product liability claims are brought against us, it may result in reduced demand for our products and product candidates or damages that exceed our insurance coverage.
  • Reforms in the healthcare industry and the uncertainty associated with pharmaceutical pricing, reimbursement and related matters could adversely affect the marketing, pricing and demand for our products, if approved.
  • Governments outside the United States tend to impose strict price controls and reimbursement approval policies, which may adversely affect our prospects for generating revenue.
  • Our ability to utilize net operating loss carryforwards may be limited.
  • Our corporate structure may create U.S. federal income tax inefficiencies
  • We are a holding company with no operations of our own.
  • Risks Related to Our Financial Condition and Capital Requirements
  • Servicing our debt and settling conversion requests may require a significant amount of cash, and we may not have sufficient cash flow from our business to pay our debt. Furthermore, restrictive covenants governing our indebtedness may restrict our ability to raise additional capital.
  • Our significant level of indebtedness could adversely affect our business, results of operations and financial condition and prevent us from fulfilling our obligations under our convertible notes and our other indebtedness.
  • Any conversion of our outstanding convertible notes into common stock will dilute the ownership interest of our existing stockholders, including holders who had previously converted their notes.
  • The fundamental change purchase feature of our outstanding convertible notes may delay or prevent an otherwise beneficial attempt to take over our company.
  • We currently have no significant product revenues and need to raise additional capital to operate our business, which may not be available on favorable terms, or at all, and which will have a dilutive effect on our stockholders.
  • We are not currently profitable and delays in achieving profitability, if at all, will have a material adverse effect on our business and results of operations and could negatively impact the value of our common stock.
  • Risks Related to the Commercialization of Drug Products
  • There has been continued non-compliance with the terms and conditions of the Brazil Agreement.
  • We have limited experience in selling, marketing or distributing products and limited internal capability to do so.
  • We may enter into distribution arrangements and marketing alliances for certain products and any failure to successfully identify and implement these arrangements on favorable terms, if at all, may impair our ability to commercialize our product candidates.
  • If physicians, patients, third party payors and others in the medical community do not accept and use taliglucerase alfa, or any of our other product candidates, if approved, our ability to generate revenue from product sales will be materially impaired.
  • If the market opportunities for other product candidates, and for BioManguinhos alfataliglicerase in Brazil, are smaller than we believe they are, our revenues may be adversely affected and our business may suffer.
  • Coverage and reimbursement may not be available for one or more of our product candidates, if approved, in all territories, which could diminish our sales or affect our ability to sell any such products profitably.
  • We and our collaborating partners may be subject, directly or indirectly, to federal and state healthcare fraud and abuse and false claims laws and regulations. If we or our collaborating partners are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Risks Related to Intellectual Property Matters
  • The intellectual property and assets owned by our subsidiaries are subject to security agreements that secure our payment and other obligations under our 2021 Notes, and our subsidiaries have guaranteed all of those obligations.
  • If we fail to adequately protect or enforce our intellectual property rights or secure rights to third party patents, the value of our intellectual property rights would diminish and our business, competitive position and results of operations would suffer.
  • We rely on confidentiality agreements that could be breached and may be difficult to enforce which could have a material adverse effect on our business and competitive position.
  • If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages and required to defend against litigation which could result in substantial costs and may have a material adverse effect on our business, results of operations and financial condition.
  • If we cannot meet requirements under our license agreements, we could lose the rights to our products, which could have a material adverse effect on our business.
  • Risks Relating to Our Operations in Israel
  • Potential political, economic and military instability in the State of Israel, where the majority of our senior management and our research and development facilities are located, may adversely affect our results of operations.
  • Our operations may be disrupted by the obligations of our personnel to perform military service which could have a material adverse effect on our business.
  • Because a certain portion of our expenses is incurred in New Israeli Shekels, our results of operations may be seriously harmed by currency fluctuations and inflation.
  • The tax benefits available to us require that we meet several conditions and may be terminated or reduced in the future, which would increase our taxes.
  • The Israeli government grants we have received for certain research and development expenditures restrict our ability to manufacture products and transfer technologies outside of Israel and require us to satisfy specified conditions. If we fail to satisfy these conditions, we may be required to refund grants previously received together with interest and penalties which could have a material adverse effect on our business and results of operations.
  • Investors may have difficulties enforcing a U.S. judgment, including judgments based upon the civil liability provisions of the U.S. federal securities laws against us, our executive officers and most of our directors or asserting U.S. securities laws claims in Israel.
  • Risks Related to Investing in our Common Stock
  • The market price of our common stock may fluctuate significantly.
  • Future sales of our common stock could reduce our stock price.
  • If securities analysts stop publishing research or reports about us or our business or if they downgrade our common stock, the market price of our common stock could decline.
  • Our common stock is listed to trade on more than one stock exchange, and this may result in price variations.
  • Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses, divert management’s attention from operating our business which could have a material adverse effect on our business.
  • The issuance of preferred stock or additional shares of common stock could adversely affect the rights of our stockholders.
Content analysis
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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. sophomore Good
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