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Annexon (ANNX)

Annexon, Inc., doing business as Annexon Biosciences, operates as a clinical-stage biopharmaceutical company. The Company develops novel therapies for auto-immune and neurodegenerative diseases of body, eye, and brain. Annexon Biosciences serves patients in the State of California.

Company profile

Ticker
ANNX
Exchange
CEO
Douglas Love
Employees
Incorporated
Location
Fiscal year end
SEC CIK
Subsidiaries
Annexon Biosciences Australia Pty Ltd ...
IRS number
275414423

ANNX stock data

Analyst ratings and price targets

Last 3 months

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

8 Aug 22
1 Oct 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
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) 105.65M 105.65M 105.65M 105.65M 105.65M 105.65M
Cash burn (monthly) 2.78M (no burn) 12.47M 12.16M 9.39M 9.71M
Cash used (since last report) 8.51M n/a 38.13M 37.2M 28.71M 29.69M
Cash remaining 97.14M n/a 67.51M 68.45M 76.94M 75.96M
Runway (months of cash) 34.9 n/a 5.4 5.6 8.2 7.8

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
11 Jul 22 Lew Jennifer Common Stock Grant Acquire A No No 0 9,375 0 23,875
11 Jul 22 Lew Jennifer Stock Option Common Stock Grant Acquire A No No 3.91 75,000 293.25K 75,000
11 Jul 22 Douglas Love Stock Option Common Stock Grant Acquire A No No 3.91 300,000 1.17M 300,000
11 Jul 22 Douglas Love Stock Option Common Stock Grant Acquire A No No 3.91 300,000 1.17M 300,000
11 Jul 22 Larry Mattheakis Common Stock Grant Acquire A No No 0 4,688 0 17,188
11 Jul 22 Larry Mattheakis Stock Option Common Stock Grant Acquire A No No 3.91 37,500 146.63K 37,500
11 Jul 22 Larry Mattheakis Common Stock Grant Acquire A No No 0 4,688 0 17,188
11 Jul 22 Larry Mattheakis Stock Option Common Stock Grant Acquire A No No 3.91 37,500 146.63K 37,500
13F holders Current Prev Q Change
Total holders 85 107 -20.6%
Opened positions 21 24 -12.5%
Closed positions 43 20 +115.0%
Increased positions 10 34 -70.6%
Reduced positions 37 24 +54.2%
13F shares Current Prev Q Change
Total value 900.82M 345.14M +161.0%
Total shares 54.81M 48.88M +12.1%
Total puts 142.1K 12.9K +1001.6%
Total calls 290.1K 28K +936.1%
Total put/call ratio 0.5 0.5 +6.3%
Largest owners Shares Value Change
BVF 3.78M $14.25M NEW
Eventide Asset Managment 3.63M $13.67M 0.0%
Redmile 3.5M $13.21M +9.4%
Biotechnology Value Fund L P 3.34M $11.03M NEW
Bain Capital Life Sciences Investors 3.24M $12.22M 0.0%
FHI Federated Hermes 3.05M $11.51M +0.0%
Bain Capital Life Sciences Fund 2.94M $73.6M 0.0%
Fairmount Funds Management 2.89M $10.91M NEW
New Enterprise Associates 15 2.5M $62.47M 0.0%
Pictet Asset Management 2.23M $8.4M -0.0%
Largest transactions Shares Bought/sold Change
BVF 3.78M +3.78M NEW
Biotechnology Value Fund L P 3.34M +3.34M NEW
Fairmount Funds Management 2.89M +2.89M NEW
Alliancebernstein 0 -2.48M EXIT
Venrock Healthcare Capital Partners II 1.93M +1.93M NEW
VR Adviser 1.93M +1.93M NEW
BLK Blackrock 961.04K -1.61M -62.6%
TROW T. Rowe Price 0 -1.32M EXIT
STT State Street 88.84K -467.31K -84.0%
Woodline Partners 409.63K +409.63K NEW

Financial report summary

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Competition
IVERIC bio
Risks
  • We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future, which, together with our limited operating history, makes it difficult to assess our future viability.
  • We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
  • Due to the significant resources required for the development of our product candidates, we must prioritize development of certain product candidates and/or certain disease indications. We may expend our limited resources on candidates or indications that do not yield a successful product and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.
  • Our business is heavily dependent on the successful development, regulatory approval and commercialization of our product candidates which are in early stages of clinical development.
  • Public health crises such as pandemics or similar outbreaks could materially and adversely affect our preclinical and clinical trials, business, financial condition and results of operations.
  • Research and development of biopharmaceutical products is inherently risky. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized.
  • We may encounter substantial delays in our clinical trials or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Adverse events or undesirable side effects caused by, or other unexpected properties of, any of our product candidates could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • Interim “top-line” and preliminary data from studies or trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Clinical trials of ANX005 in combination with IVIg in patients with GBS will provide no evidence of the efficacy of ANX005.
  • Even if our current or future product candidates obtain regulatory approval, they may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.
  • We have received Orphan Drug designation for ANX005 for the treatment of GBS and HD, and we may seek Orphan Drug designation for certain future product candidates. We may be unable to obtain such designations or to maintain the benefits associated with Orphan Drug designation, including market exclusivity, which may cause any revenue from product sales to be reduced.
  • A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
  • Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
  • If the product candidates that we develop receive regulatory approval in the United States or another jurisdiction, they may never receive approval in other jurisdictions, which would limit market opportunities for our product candidates and adversely affect our business.
  • Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • We rely on third-party suppliers to manufacture our product candidates, and we intend to rely on third parties to produce commercial supplies of any approved product. The loss of these suppliers, or their failure to comply with applicable regulatory requirements or to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
  • We rely on third parties in the conduct of all of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, fail to comply with applicable regulatory requirements or meet expected deadlines, we may be unable to obtain regulatory approval for our product candidates.
  • We face significant competition in an environment of rapid technological and scientific change, and our product candidates, if approved, will face significant competition, which may prevent us from achieving significant market penetration. Most of our competitors have significantly greater resources than we do, and we may not be able to successfully compete.
  • The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  • We currently have no sales organization. If we are unable to establish sales capabilities on our own or through third parties, we may not be able to market and sell our product candidates, if approved, effectively in the United States and foreign jurisdictions or generate product revenue.
  • We will need to increase the size of our organization, and we may experience difficulties in managing growth.
  • If we fail to attract and retain senior management and key scientific personnel, our business may be materially and adversely affected.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates.
  • Any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.
  • Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of operations.
  • We or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Our employees and independent contractors, including principal investigators, consultants, any future commercial collaborators, service providers and other vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • Our business involves the use of hazardous materials, and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
  • Our current and any future product candidates or products could be alleged to infringe patent rights and other proprietary rights of third parties, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages and/or limit our ability to commercialize our products.
  • If we are unable to obtain, maintain and enforce intellectual property protection directed to our current and any future technologies that we develop, others may be able to make, use or sell products substantially the same as ours, which could adversely affect our ability to compete in the market.
  • If we are unable to prevent disclosure of our trade secrets or other confidential information to third parties, our competitive position may be impaired.
  • We license patent rights from third-party owners. Such licenses may be subject to early termination if we fail to comply with our obligations in our licenses with third parties, which could result in the loss of rights or technology that are material to our business.
  • Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.
  • We may wish to form collaborations in the future with respect to our product candidates, but may not be able to do so or to realize the potential benefits of such transactions, which may cause us to alter or delay our development and commercialization plans.
  • We jointly own certain patent rights with third parties. Our ability to out-license these patent rights, or to prevent the third party from out-licensing these patent rights, may be limited in certain countries.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
  • Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the prices we may set.
  • If we develop a small molecule product candidate that obtains regulatory approval, additional competitors could enter the market with generic versions of such drugs, which may result in a material decline in sales of affected products.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Our stock price may be volatile and you may not be able to resell shares of our common stock at or above the price you paid.
  • An active, liquid and orderly market for our common stock may not develop, and you may not be able to resell your common stock at or above the price you paid.
  • As of December 31, 2021, we are no longer an “emerging growth company,” and the reduced disclosure and governance requirements applicable to emerging growth companies no longer apply to us.
  • We incur significant costs as a result of operating as a public company, and our management needs to devote substantial time to compliance initiatives. We may fail to comply with the rules that apply to public companies, which could result in sanctions or other penalties that could materially and adversely affect our business, financial condition, results of operations and prospects.
  • If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations which may adversely affect investor confidence in us and, as a result, the value of our common stock.
  • If we sell shares of our common stock in the future, stockholders may experience immediate dilution and, as a result, our stock price may decline.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • As a California-domiciled public company, we are required to have a certain number of women and directors from underrepresented communities on our board of directors on certain timeframes, depending on the size of our board at the time.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for certain 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.
  • We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Changes in tax laws and regulations may have a material adverse effect on our business, financial condition and results of operations.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Significant disruptions of information technology systems, breaches of data security and other incidents could materially adversely affect our business, results of operations and financial condition.
  • Actual or perceived failure to comply with applicable data protection laws, regulations, standards and other requirements could lead to government enforcement actions and civil or criminal penalties, private litigation or adverse publicity and could negatively affect our operating results and business.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
Management Discussion
  • Research and development expenses increased by $50.8 million, or 103%, for the year ended December 31, 2021 compared to the year ended December 31, 2020. The increase was primarily due to an increase of $23.7 million in direct clinical outside services related to our multiple ongoing and planned clinical trials in GBS, warm autoimmune hemolytic anemia, Huntington’s Disease, amyotrophic lateral sclerosis and geographic atrophy as well as preclinical outside services to support pre-IND activities for ANX105 and our small molecule program, ANX1502. Contract manufacturing expense increased by $6.7 million related to the production of ANX005, ANX007, and ANX009 as well as pre-IND manufacturing activities for ANX105 and ANX1502. Compensation and personnel-related expenses increased by $12.5 million, including an increase of $6.3 million in stock-based compensation, due to an increase in headcount. Direct consulting and professional services costs increased by $4.1 million related to the support of multiple functions including clinical development, translational, regulatory and project management. Facilities and depreciation costs increased by $3.7 million due to the commencement of our new office lease in Brisbane, California.

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