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Bellerophon Therapeutics (BLPH)

Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing multiple product candidates under its INOpulse® program, a proprietary pulsatile nitric oxide delivery system.

BLPH stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

15 Aug 22
28 Sep 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 16.33M 16.33M 16.33M 16.33M 16.33M 16.33M
Cash burn (monthly) 1.22M 1.5M 2.18M 1.77M 1.22M 1.5M
Cash used (since last report) 3.61M 4.42M 6.44M 5.23M 3.61M 4.42M
Cash remaining 12.71M 11.91M 9.89M 11.1M 12.71M 11.91M
Runway (months of cash) 10.4 8.0 4.5 6.3 10.4 8.0

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
26 Jan 22 Parag Suresh Shah RSU Common Stock Grant Acquire A No No 0 51,000 0 51,000
26 Jan 22 Nicholas Laccona RSU Common Stock Grant Acquire A No No 0 36,000 0 36,000
26 Jan 22 Martin Dekker RSU Common Stock Grant Acquire A No No 0 51,000 0 51,000
26 Jan 22 Peter Fernandes RSU Common Stock Grant Acquire A No No 0 65,000 0 65,000
31 Dec 21 Crispin Teufel Stock Options Common Stock Grant Acquire A No No 3.1 21,828 67.67K 33,087
22.5% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 23 10 +130.0%
Opened positions 13 0 NEW
Closed positions 0 13 EXIT
Increased positions 1 2 -50.0%
Reduced positions 4 3 +33.3%
13F shares Current Prev Q Change
Total value 9.41M 7.97M +18.1%
Total shares 2.15M 1.41M +52.4%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners Shares Value Change
New Mountain Investments II 1.01M $6.73M 0.0%
Vanguard 360.79K $852K NEW
WFC Wells Fargo & Co. 200.05K $472K NEW
Renaissance Technologies 185.3K $437K +3.6%
BLK Blackrock 120.69K $285K -0.8%
Telemetry Investments, L.L.C. 83.58K $197K NEW
Geode Capital Management 58.34K $137K -0.0%
Jane Street 37.33K $88K NEW
NTRS Northern Trust 28.1K $66K -22.8%
STT State Street 21.33K $50K NEW
Largest transactions Shares Bought/sold Change
Vanguard 360.79K +360.79K NEW
WFC Wells Fargo & Co. 200.05K +200.05K NEW
Telemetry Investments, L.L.C. 83.58K +83.58K NEW
Jane Street 37.33K +37.33K NEW
STT State Street 21.33K +21.33K NEW
Tudor Investment Corp Et Al 20K +20K NEW
Millennium Management 11.08K +11.08K NEW
NTRS Northern Trust 28.1K -8.31K -22.8%
Renaissance Technologies 185.3K +6.4K +3.6%
UBS UBS Group AG - Registered Shares 2.57K +2.57K NEW

Financial report summary

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Risks
  • We have incurred significant losses since inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.
  • Our limited operating history may make it difficult for our stockholders to evaluate the success of our business to date and to assess our future viability.
  • We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to technologies or product candidates.
  • We may not be able to utilize all of our net operating loss carryforwards.
  • We face substantial competition from other pharmaceutical, biotechnology and medical device companies and our operating results may suffer if we fail to compete effectively.
  • We are dependent on the success of our INOpulse product candidates and our ability to develop, obtain marketing approval for and successfully commercialize these product candidates. If we continue to be unable to develop, obtain marketing approval for or successfully commercialize our product candidates, either alone or through a collaboration, or experience significant delays in doing so, our business could be materially harmed.
  • Clinical trials involve a lengthy and expensive process with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • INOpulse is a sophisticated electro-mechanical device comprised of components that may fail or deteriorate over time or with improper use. If we experience problems with, failure of, or delays in obtaining any INOpulse components, our business could be materially adversely harmed.
  • We have conducted, and may in the future conduct, clinical trials for certain of our product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.
  • Some clinical trials of our product candidates failed to demonstrate safety and efficacy of our product candidates to the satisfaction of the FDA and if other clinical trials also fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S. regulators, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates.
  • We have experienced and may continue to experience a number of possible undesirable events in connection with clinical trials of our product candidates, potential marketing approval or commercialization of our product candidates could be delayed or prevented.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, we may not achieve our clinical development on our anticipated timeline, or at all, and our receipt of necessary regulatory approvals could be delayed or prevented.
  • We may not obtain orphan drug exclusivity for any of our product candidates and indications, or we may not receive the full benefit of orphan drug exclusivity even if we obtain such exclusivity.
  • Serious adverse events, or SAEs, or undesirable side effects or other unexpected properties of our product candidates have been identified in past clinical trials and may be identified during development of other treatments that could delay or prevent the product candidate’s marketing approval.
  • We may not be successful in our efforts to identify or discover additional potential product candidates.
  • If any of our product candidates receives marketing approval and we, or others, later discover that the product is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the product could be adversely affected.
  • Even if one of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, and the market opportunity for the product candidate may be smaller than we estimate.
  • If we are unable to establish sales, marketing and distribution capabilities or enter into acceptable sales, marketing and distribution arrangements with third parties, we may not be successful in commercializing any product candidates that we develop, if and when those product candidates are approved.
  • Even if we are able to commercialize any product candidate that we develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives that could harm our business.
  • If the FDA or comparable non-U.S. regulatory authorities approve generic versions of any of our products that receive marketing approval, or such authorities do not grant our products appropriate periods of data exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.
  • Product liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
  • Our INOpulse devices use lithium-ion battery cells, which have been observed to catch fire or vent smoke and flame, and these events may raise concerns about the batteries we use.
  • The intellectual property underlying INOpulse is exclusively licensed from Ikaria. If Ikaria terminates the license agreement, or fails to prosecute, maintain or enforce the underlying patents, our business will be materially harmed.
  • We rely, and expect to continue to rely, on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.
  • We rely on third-party suppliers and manufacturers to produce and deliver clinical devices and supplies as well as for the servicing of these devices for our INOpulse product candidates, and may also do so for other product candidates. Any failure by a third-party supplier or manufacturer to produce or deliver supplies for us or to provide necessary servicing may delay or impair our ability to complete our clinical trials or commercialize our product candidates.
  • Our product candidates currently in development are exclusively licensed from third parties, and we may enter into additional agreements to in-license technology from third parties. If current or future licensors terminate the applicable license, or fail to maintain or enforce the underlying patents, our competitive position and market share will be harmed.
  • Third parties may seek to hold us responsible for liabilities of Ikaria that we did not assume in our agreements.
  • Any disputes that arise between us and Ikaria with respect to our past and ongoing relationships could harm our business operations.
  • We may seek to enter into collaborations with third parties for the development and commercialization of our product candidates. If we fail to enter into such collaborations, or such collaborations are not successful, we may not be able to capitalize on the market potential of our product candidates.
  • If we are not able to establish collaborations, we may have to alter our development and commercialization plans.
  • If we are unable to obtain and maintain patent protection for our technology and products or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
  • If we fail to comply with our obligations under license agreements, we could lose rights that are important to our business.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We are increasingly dependent on information technology and our systems and infrastructure face certain risks, including cybersecurity and data storage risks.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Even if we complete the necessary clinical trials, the marketing approval process is expensive, time consuming and uncertain and may prevent us from obtaining approvals for the commercialization of some or all of our product candidates. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.
  • Our failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad, and any approval we are granted for our product candidates in the United States would not assure approval of product candidates in foreign jurisdictions.
  • Even if we obtain marketing approval for our product candidates, the terms of approvals and ongoing regulation of our products may limit how we manufacture and market our products and compliance with such requirements may involve substantial resources, which could materially impair our ability to generate revenue.
  • Any product candidate for which we obtain marketing approval will be subject to strict enforcement of post-marketing requirements and we could be subject to substantial penalties, including withdrawal of our product from the market, if we fail to comply with all regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.
  • We will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations after we obtain FDA approval and begin to commercialize our products, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates and products outside of the United States and require us to develop and implement costly compliance programs.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
  • Changes in law or policy could have a negative impact on the approval of our drug candidates.
  • Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Recent and pending management changes could disrupt our operations and impair our ability to attract and retain key personnel.
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • A significant portion of our total outstanding shares are subject to volume limitations as to sale, but have registration rights that could allow them to be sold into the market without such restrictions, which could cause the market price of our common stock to drop significantly, even if our business is performing well.
  • If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price or trading volume of our stock could decline.
  • The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for our stockholders.
  • An active trading market for our common stock may not be sustained.
  • We have broad discretion in the use of our cash and cash equivalents and may not use them effectively.
  • We are incurring significant increased costs and demands upon management as a result of operating as a public company.
  • Our certificate of incorporation provides that the doctrine of “corporate opportunity” will not apply to any of our stockholders or directors, except in limited circumstances, which may adversely affect our business or prospects.
  • Our certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Provisions in our certificate of incorporation, our bylaws or Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders.
Management Discussion
  • Total Operating Expenses. Total operating expenses for the year ended December 31, 2021 were $20.2 million compared to $26.3 million for the year ended December 31, 2020, a decrease of $6.1 million, or 23%. This decrease was due to a decrease in research and development expenses primarily attributable to the discontinuation of the COVID-19 trial in the current year as well as a decrease in our general and administrative expenses.
  • Research and Development Expenses. Total research and development expenses for the year ended December 31, 2021 were $13.0 million compared to $17.9 million for the year ended December 31, 2020, a decrease of $4.9 million, or 27%. The decrease in research and development expenses was primarily attributable to the decrease in expenses related to the COVID-19 trial in 2021 due to our discontinuation of such trial. Total research and development expenses consisted primarily of the following:
  • General and Administrative Expenses. General and administrative expenses for the year ended December 31, 2021 were $7.1 million compared to $8.4 million for the year ended December 31, 2020, a decrease of $1.3 million, or 15%. The decrease was primarily due to reduced consulting and labor costs.

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