Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  Nasdaq  >  Akcea Therapeutics, Inc.    AKCA

AKCEA THERAPEUTICS, INC.

(AKCA)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsPress ReleasesOfficial PublicationsSector news
The feature you requested does not exist. However, we suggest the following feature:

AKCEA THERAPEUTICS : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q)

share with twitter share with LinkedIn share with facebook
08/05/2020 | 03:31pm EDT

In this Report on Form 10-Q, unless the context requires otherwise, "Akcea," "Company," "we," "our," and "us," means Akcea Therapeutics, Inc. and our subsidiaries.

Forward-Looking Statements

In addition to historical information contained in this Report on Form 10-Q, this Report includes forward-looking statements regarding our financial position, outlook, business, and the therapeutic use and commercialization of TEGSEDI®, WAYLIVRA® and our other products in development. Any statement describing our goals, expectations, financial or other projections, intentions or beliefs, is a forward-looking statement and should be considered an at-risk statement. Words such as "may," "could," "should," "would," "believe," "expect," "expectation," "anticipate," "estimate," "intend," "seeks," "plan," "project," "continue," "predict," "will," and other words or expressions of similar meaning are intended by us to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to certain risks and uncertainties, particularly risks related to our financial condition and need for additional capital, the clinical development and regulatory review and approval of our medicines, the commercialization of our medicines, our dependence on third parties to develop and commercialize our medicines, our relationship with Ionis Pharmaceuticals, Inc., our controlling stockholder, and risks related to our business and industry generally, such as risks inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics. Our forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Although our forward-looking statements reflect the good faith judgment of our management, these statements are based only on facts and factors currently known by us. As a result, you are cautioned not to rely on these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified in this Quarterly Report on Form 10-Q and those discussed in the section titled "Risk Factors" set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q and in our other Securities and Exchange Commission, or SEC, filings. In particular, we caution you that our forward-looking statements are subject to the ongoing and developing circumstances related to the COVID-19 Pandemic, which may have a material adverse effect on our business, operations and future financial results. You should not rely upon forward-looking statements as predictions of future events. Furthermore, such forward-looking statements, like all statements in the Report, speak only as of the date of this Report (unless another date is indicated). Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

The following discussion and analysis should be read in conjunction with (1) our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q, and (2) the audited financial statements and accompanying notes thereto and the related Management's Discussion and Analysis of Financial Condition and Results of Operations for the fiscal year ended December 31, 2019, which are contained in our Annual Report on the Form 10-K for the fiscal year ended on December 31, 2019 filed on March 2, 2020 with the SEC. Our consolidated financial information may not be indicative of our future performance.

Overview

We are a commercial-stage biopharmaceutical company developing and marketing transformative medicines to treat patients with serious and rare diseases. Our large and potentially advancing pipeline of medicines in late-stage development and medicines on the market allows us to capitalize on our strengths in supporting patients, healthcare professionals and caregivers in treating serious and rare diseases. To optimize the value of our medicines to treat larger patient populations, we add to our own capabilities the strengths of partners to provide additional expertise, resources and commercial capabilities. We believe our strong relationship with our majority shareholder, Ionis Pharmaceuticals, Inc., or Ionis, should allow us to continue to expand our pipeline.

We have a robust portfolio of antisense medicines, both on the market and in development, covering multiple targets and diseases that we have licensed from Ionis. We are highly focused on commercializing our approved therapies, TEGSEDI and WAYLIVRA. TEGSEDI is indicated to treat adults with the polyneuropathy caused by hereditary transthyretin-mediated amyloidosis, or hATTR amyloidosis, and has been approved and commercialized in the United States, or U.S., the European Union, or E.U. and Canada as well as approved in Brazil. WAYLIVRA is indicated as an adjunct to diet to treat adult patients with genetically confirmed familial chylomicronemia syndrome, or FCS, who are at high risk for pancreatitis, for whom response to diet and triglyceride lowering therapy has been inadequate. WAYLIVRA has been approved and commercialized in the E.U. A Marketing Authorization Application was submitted to ANVISA in Brazil through PTC Therapeutics International Limited, or PTC Therapeutics, for WAYLIVRA.


                                       27

--------------------------------------------------------------------------------

We are advancing a mature pipeline of novel medicines with the potential to treat multiple diseases. In addition to TEGSEDI and WAYLIVRA, our pipeline includes two medicines in Phase 3 clinical trials, AKCEA-APO(a)-LRx, which is partnered with Novartis Pharma AG, or Novartis, and AKCEA-TTR-LRx. We also have two additional medicines that have each completed a positive Phase 2 clinical trial, AKCEA-ANGPTL3-LRx, which is now called vupanorsen and is partnered with Pfizer, Inc., or Pfizer, and AKCEA-APOCIII-LRx. All of our medicines are based on Ionis' antisense technology platform. Our medicines in development use Ionis' advanced LIgand Conjugated Antisense, or LICA, technology, which enhances the effective uptake and activity of these medicines in particular tissues.

We are continuing to optimize our current commercial infrastructure for TEGSEDI and WAYLIVRA, and plan to use this infrastructure for the other medicines in our pipeline. A key element of our commercial strategy is to provide the specialized, patient-centric support required to successfully address serious and rare disease patient populations. We believe our focus on treating patients with inadequately addressed serious and rare diseases allows us to partner efficiently and effectively with the specialized medical community that supports these underserved patient communities. For example, we created Akcea Connect, a drug treatment program composed of dedicated, regionally-based nurse case managers who have a wide range of medical knowledge and experience. This program offers free, private and personalized support to patients, their caregivers and their families in the U.S. Internationally, we are introducing Akcea Connect in each of the countries where our products are available with the highest level of patient and physician support allowed by local regulations. Express Scripts' Accredo Health Group, Inc., or Accredo is our specialty pharmacy partner for the distribution of TEGSEDI in the U.S. We chose Accredo because of its experience with the unique needs of rare disease communities and its proven track record for simplifying access to therapy. Accredo has a team of specialty clinicians, pharmacists and approximately 600 field-based nurses located throughout the U.S. who are augmenting the Akcea Connect team of nurse case managers to provide support and address the needs of the hATTR amyloidosis community. To further support the hATTR amyloidosis community, we and Ambry Genetics Corporation, or Ambry, a Konica Minolta company, launched hATTR Compass™ in the U.S. and Canada, a free-of-charge, confidential genetic testing and genetic counseling program for people suspected to have hATTR amyloidosis. This program is intended to empower patients and their caregivers by providing accurate genetic information, so they can make informed decisions about their healthcare.

Our efforts to treat people with serious and rare diseases are currently focused on transthyretin amyloidosis, or ATTR amyloidosis, and cardiometabolic diseases.

ATTR

TEGSEDI is an antisense medicine designed to reduce the production of the transthyretin, or TTR protein. hATTR amyloidosis is a severe, progressive and life-threatening disease caused by the abnormal formation of the TTR protein and aggregation of TTR amyloid deposits in various tissues and organs throughout the body, including in peripheral nerves, the heart and intestinal tract. The progressive accumulation of TTR amyloid deposits in these organs often leads to intractable peripheral sensorimotor neuropathy, autonomic neuropathy and/or cardiomyopathy, as well as other disease manifestations. hATTR amyloidosis causes significant morbidity and progressive decline in quality of life, severely impacting activities of daily living. The disease often progresses rapidly and can lead to premature death. The median survival is 4.7 years following diagnosis.

We estimate that there are approximately 50,000 patients globally with hATTR amyloidosis, the majority of whom have symptoms of polyneuropathy.

TEGSEDI was discovered and developed by Ionis and was licensed by us in April 2018. In addition to TEGSEDI, we and Ionis are co-developing AKCEA-TTR-LRx for hereditary and wild-type forms of transthyretin amyloidosis, or ATTR amyloidosis. We and Ionis initiated clinical development of AKCEA-TTR-LRx in December 2018 and presented positive Phase 1 data results in September 2019. The data showed a >90% knockdown of TTR following administration in healthy volunteers and a positive safety and tolerability profile. In November 2019, we and Ionis initiated a broad Phase 3 program, starting with the NEURO-TTRansform Phase 3 clinical trial for AKCEA-TTR-LRx in patients with polyneuropathy caused by hATTR amyloidosis. In January 2020, we and Ionis announced the initiation of the CARDIO-TTRansform Phase 3 cardiovascular outcomes clinical trial for AKCEA-TTR-LRx in patients with transthyretin-mediated amyloid cardiomyopathy, or ATTR cardiomyopathy.

In April 2020, results from the ongoing, open-label extension, or OLE, study of the pivotal NEURO-TTR trial were published in the European Journal of Neurology. The primary objective of the OLE study was to evaluate the safety and tolerability of long-term treatment with TEGSEDI. Secondary objectives of the study included understanding progression based on measures such as the modified Neuropathy Impairment Score +7 (mNIS+7) and the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QoL-DN). Understanding changes over time in generic health-related quality of life based on the Short Form 36 Health Survey (SF-36) was an exploratory objective. This interim analysis, published in the European Journal of Neurology, shows that treatment with TEGSEDI was not associated with additional safety concerns or signs of increased toxicity in study participants treated for up to five years. Treatment with TEGSEDI resulted in continued efficacy in patients after two years. Results also showed that patients who started treatment with TEGSEDI earlier (received TEGSEDI treatment in the NEURO-TTR study) achieved greater long-term disease stabilization compared to those who switched from placebo to TEGSEDI in the OLE study.


                                       28

--------------------------------------------------------------------------------

Cardiometabolic

Our lipid/cardiometabolic medicines, WAYLIVRA, AKCEA-APO(a)-LRx, AKCEA-APOCIII-LRx and vupanorsen, are all based on antisense technology developed by Ionis. WAYLIVRA was granted conditional marketing authorization approval in the E.U. on May 3, 2019 and commercially launched in the E.U. in August 2019. We are commercializing WAYLIVRA across the E.U. The approval of WAYLIVRA in the E.U. followed a positive recommendation by the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, as an adjunct to diet in adult patients with genetically confirmed FCS who are at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate. We are leveraging and optimizing our existing commercial infrastructure in Europe to market WAYLIVRA. In addition, we are focused on regulatory discussions for WAYLIVRA in the U.S. and Canada. On May 10, 2018, the U.S. Food and Drug Administration's, or FDA's, Endocrinologic and Metabolic Drugs Advisory Committee voted to support approval of WAYLIVRA for the treatment of people with FCS. On August 27, 2018, we and Ionis announced that we received a Complete Response Letter from the Division of Metabolism and Endocrinology Products of the FDA regarding the New Drug Application for WAYLIVRA. The FDA did not cite any new concerns beyond those described in the Advisory Committee briefing book, in which the main areas of focus were the dosing schedule and management of thrombocytopenia. We continue to feel strongly that WAYLIVRA demonstrates a favorable benefit/risk profile in people with FCS, as was reflected in the positive outcome from the Advisory Committee meeting. In November 2018, we received a Notice of Noncompliance withdrawal letter, or NON-W, from Health Canada for WAYLIVRA. Our discussions with the FDA are ongoing and we plan to refile.

FCS is a serious and rare disease caused by impaired function of the enzyme lipoprotein lipase, or LPL, and characterized by severe hypertriglyceridemia and a risk of acute pancreatitis. Further, the lives of patients with this disease are impacted daily by the associated symptoms. In our Phase 3 clinical trial, we have observed consistent and substantial (>70%) decreases in triglycerides and improvements in other manifestations of FCS, including pancreatitis attacks and abdominal pain. The final study results from the Phase 3 APPROACH clinical trial were published in the August 2019 issue of The New England Journal of Medicine. We believe the safety and efficacy data from the WAYLIVRA program demonstrate a favorable risk-benefit profile for patients with FCS. The FDA and the EMA have granted orphan drug designation to WAYLIVRA for the treatment of patients with FCS.

AKCEA-APO(a)-LRx completed Phase 2 in 2018 and Novartis has initiated the Phase 3 program. This medicine was recently granted Fast Track Designation by the FDA as a potential treatment for people at significant risk for cardiovascular disease due to elevated levels of lipoprotein(a), or Lp(a).

On January 2, 2020, results from the Phase 2 clinical trial evaluating AKCEA-APO(a)-LRx in patients with established cardiovascular disease, or CVD, and elevated levels of lipoprotein(a), or Lp(a), were published in The New England Journal of Medicine, or NEJM.

The randomized, double-blind, placebo-controlled, dose-ranging study of 286 patients with established CVD and elevated Lp(a) is the largest ever conducted specifically for people with elevated Lp(a). It is also the largest and longest study to date evaluating the Ionis LICA technology platform, with patients treated for up to 1 year and all patients treated for a minimum of six months.

The study demonstrated that, following treatment, patients experienced significant dose-dependent reductions in Lp(a) at all dose levels studied with up to an 80% reduction in Lp(a) at the highest cumulative dose regimen. Approximately 98% of patients at the 80 mg monthly dose regimen achieved Lp(a) levels below 125 nmol/L (~50 mg/dL). Significant dose-dependent reductions in LDL-C, apoB, OxPL-apoB and OxPL-apo(a) from baseline were also observed. The majority of adverse events were mild or moderate, with the most frequent adverse events being injection site reactions, or ISRs. ISRs occurred in 27% and 6% of patients on treatment and those on placebo, respectively, and were mostly mild. One patient discontinued treatment due to an ISR. There were no differences in platelet counts, liver and renal parameters, or flu-like symptoms in patients administered AKCEA-APO(a)-LRx compared to patients administered placebo. AKCEA-APO(a)-LRx is continuing to progress well and is on track for a data readout in 2024.

On January 22, 2020, we and Ionis announced positive topline data results from the Phase 2 clinical trial of AKCEA-APOCIII-LRx in 114 patients with hypertriglyceridemia who are at risk for or have established CVD. The objective of the Phase 2 multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial was to evaluate the safety and efficacy of different doses and dosing frequencies of AKCEA-APOCIII-LRx. The study met the primary endpoint of significant triglyceride lowering and multiple secondary endpoints with a favorable safety and tolerability profile. We plan to initiate a Phase 3 clinical trial in patients with FCS this year.


                                       29

--------------------------------------------------------------------------------

On January 28, 2020, we and Ionis announced positive topline data results from the Phase 2 clinical trial of vupanorsen in 105 patients with hypertriglyceridemia, type 2 diabetes and non-alcoholic fatty liver disease, or NAFLD. The objective of the multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 clinical trial was to evaluate the safety and efficacy of vupanorsen. The study met the primary endpoint of significant triglyceride lowering and multiple secondary endpoints with a favorable safety and tolerability profile.

We and Ionis will present data from our Phase 2 clinical trial of vupanorsen and our phase 2 clinical trial of AKCEA-APOCIII-LRx at an upcoming medical congress in the third quarter of 2020.

COVID-19




Since December 2019, multiple novel strains of coronavirus, SARS-CoV-2, causing a disease referred to as COVID-19, have spread worldwide. In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic, or the COVID-19 Pandemic. The impact of the COVID-19 Pandemic on the global economy and on our business continues to be a fluid situation. We responded quickly across our organization to protect the health and safety of our team, customers and patients in our clinical trials, support our partners and vendors and mitigate risk. We continue to proactively assess, monitor and respond to domestic and international developments related to the COVID-19 Pandemic, and we have implemented risk-mitigation plans as needed to minimize the impact on our clinical trials, supply chain and business operations. In addition, at the recommendation of our COVID-19 task force, including international functional leadership and medical staff, we have taken steps to protect the health and welfare of our employees by temporarily closing our offices and generally suspending business-related travel, while continuing our efforts to serve customers and patients who rely on us.

Our marketed products are administered through self-injection in the comfort and safety of a patient's home and do not require a patient go to an infusion center or hospital for treatment. To date, our at-home services offered to patients on therapy have continued without interruption.

After careful review of our operations, while the ongoing and developing circumstances related to the COVID-19 Pandemic remain uncertain, we believe that we are well positioned to address challenges related to the COVID-19 Pandemic and to continue to advance both our commercial medicines and our clinical programs. We formed a multi-disciplinary COVID-19 task force to collect, monitor and analyze evolving information regarding the COVID-19 Pandemic and to make recommendations to our executive leadership team and board of directors regarding risk identification and mitigation planning. Thus far, our employees have rapidly adapted to working remotely and we are monitoring the COVID-19 Pandemic on a daily basis to ensure we have all necessary plans in place for mitigating disruptions in our operations, including our commercialization efforts, clinical programs and ongoing drug supply and nursing support for patients and clinicians. Like other companies, our clinical trials have experienced disruption due to access limitations to institutions currently impacted, and we may need to make further adjustments to clinical trials in the future to comply with evolving FDA guidance.

Our commitment to our patients, their caregivers and clinicians on the front lines managing serious and rare diseases is unwavering and our goal is to keep our existing patients on our medicines safely and support the initiation of appropriate new patients onto our medicines.

Commercial Infrastructure and Strategic Collaborations

We continue to optimize our current commercial infrastructure for TEGSEDI and WAYLIVRA, and plan to use this infrastructure for the other medicines in our pipeline. Depending on the geographic region, the number of patients impacted by the diseases we are treating and the regulatory environment of the local countries, we may choose to build out the commercial infrastructure ourselves, or to partner with another company for commercial sales and distribution. In August 2018, we entered into a license agreement with PTC Therapeutics, to commercialize TEGSEDI and WAYLIVRA in Latin America and certain Caribbean countries. A key element of our commercial strategy is to provide the specialized, patient-centric support required to successfully address rare disease patient populations. We believe our focus on treating patients with inadequately addressed serious and rare diseases will allow us to partner efficiently and effectively with the specialized medical community that supports these underserved patient communities.

To maximize the commercial potential of AKCEA-APO(a)-LRx, which was recently granted Fast Track Designation by the FDA, we have a strategic collaboration with Novartis. In February 2019, Novartis exercised its option to license AKCEA-APO(a)-LRx. Novartis is now responsible for all development and commercialization activities for this medicine, subject to our potential participation in co-commercialization. Novartis initiated the Lp(a) HORIZON study, a Phase 3 clinical trial of AKCEA-APO(a)-LRx in patients with established cardiovascular disease, or CVD, and elevated levels of lipoprotein(a), or Lp(a). Lp(a) HORIZON is a global CVD outcomes study in which Novartis plans to enroll more than 7,500 patients. We believe Novartis brings significant resources and expertise to the collaboration that can accelerate our ability to deliver this potential therapy to the large population of patients who have high cardiovascular risk due to elevated Lp(a).


                                       30

--------------------------------------------------------------------------------

Our strategic collaboration with Novartis has a potential aggregate transaction value of $900.0 million, plus royalties, which we will share equally with Ionis. The calculation of potential aggregate transaction value assumes that Novartis successfully develops and achieves regulatory approval for AKCEA-APO(a)-LRx in multiple indications, and that Novartis achieves pre-specified sales targets with respect to AKCEA-APO(a)-LRx. In addition to the $75.0 million upfront payment that we received in February 2017 and the $150.0 million license fee that we received in February 2019 for AKCEA-APO(a)-LRx, we are eligible to receive up to $675.0 million in milestone payments, including $25.0 million for the achievement of a development milestone, up to $290.0 million for the achievement of regulatory milestones and up to $360.0 million for the achievement of commercialization milestones. We are also eligible to receive tiered royalties in the mid-teens to low twenty percent range on net sales of AKCEA-APO(a)-LRx, and Novartis will reduce these royalties upon the expiration of certain patents or if a generic competitor negatively impacts the product in a specific country. In connection with Novartis' exercise of its option to exclusively license AKCEA-APO(a)-LRx, we and Novartis established a more definitive framework under which we may negotiate the co-commercialization of AKCEA-APO(a)-LRx between the two companies in selected markets. Included in this framework is an option by which Novartis could solely commercialize AKCEA-APO(a)-LRx in exchange for Novartis paying us increased commercial milestone payments based on sales of AKCEA-APO(a)-LRx. We will achieve the next payment of $25.0 million if Novartis reaches a specific level of enrollment related to the Phase 3 clinical trial for AKCEA-APO(a)-LRx.

Our collaboration with Novartis also included rights to AKCEA-APOCIII-LRx. In December 2019, Novartis made a strategic portfolio decision not to exercise its option and terminated its rights to AKCEA-APOCIII-LRx. Consequently, we have retained the rights to develop and commercialize AKCEA-APOCIII-LRx and are no longer entitled to any future license fees, milestone payments or royalties from Novartis relating to AKCEA-APOCIII-LRx. In January 2020, we reported positive Phase 2 top line results from this program in the treatment of patients with hypertriglyceridemia. We and Ionis plan to initiate a Phase 3 clinical trial in FCS for this medicine in 2020 and we are evaluating additional rare and broader diseases that are associated with high triglyceride levels. AKCEA-APOCIII-LRx also has the potential to favorably impact numerous other risk factors independently associated with CVD. In the second quarter of 2020, we repurchased $2.3 million of AKCEA-APOCIII-LRx active pharmaceutical ingredient, or API, from Novartis to be used to further develop AKCEA-APOCIII-LRx.

In October 2019, we entered into a collaboration with Pfizer, which has a potential aggregate transaction value of up to $1.6 billion, plus royalties, which we will share equally with Ionis. The calculation of potential aggregate transaction value assumes that Pfizer successfully develops and achieves regulatory approval for vupanorsen in multiple indications in the U.S., E.U. and Japan, and that Pfizer achieves pre-specified sales targets with respect to vupanorsen. As part of this agreement, we received an upfront payment of $250.0 million from Pfizer in November 2019, of which we paid Ionis $125.0 million as a sublicense fee in the form of 6,873,344 shares of our common stock. In addition to the upfront payment, we are eligible to receive up to $1.3 billion in milestone payments, including up to $205.0 million for the achievement of development milestones, up to $250.0 million for the achievement of regulatory milestones and up to $850.0 million for the achievement of commercialization milestones. Akcea has the right, at its option, to participate in commercialization activities with Pfizer in the United States and certain additional markets on pre-defined terms and based on meeting pre-defined criteria. We are also eligible to receive tiered royalties in the mid-teens to low twenty percent range on net sales of vupanorsen, and Pfizer will reduce these royalties upon the expiration of certain patents or if a generic competitor negatively impacts the product in a specific country. We will achieve the next payment of $75.0 million when Pfizer advances vupanorsen.

Our total revenue for the first six months of 2020 was $38.5 million. Our net loss for the first six months of 2020 was $92.4 million. Such net loss resulted from costs incurred in developing TEGSEDI, WAYLIVRA and the other medicines in our pipeline, commercializing TEGSEDI and WAYLIVRA and general and administrative activities associated with our operations, offset in part by our revenue and our loss sharing agreement with Ionis. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future. The transition to profitability is dependent upon the successful development, approval and commercialization of our products and product candidates and the achievement of a level of revenue adequate to support our cost structure. We incur meaningful expenses to support commercialization, including manufacturing, marketing, sales and distribution functions.

As of June 30, 2020, we had cash, cash equivalents and investments of $389.9 million. We plan to use our cash, cash equivalents and investments on hand as of June 30, 2020 to further our commercialization efforts for TEGSEDI and WAYLIVRA and continue the advancement of our pipeline medicines.


                                       31

--------------------------------------------------------------------------------

Our Relationship with Ionis

Ionis formed Akcea as a wholly owned subsidiary to complete development of and to commercialize Ionis' medicines to treat lipid disorders. We began business operations in January 2015 and we licensed our cardiometabolic franchise from Ionis at the beginning of 2015. Prior to licensing these medicines, Ionis' employees performed all of the development, regulatory and manufacturing activities for these medicines either themselves or through third-party providers. As such, Ionis incurred all of the expenses associated with these activities and reported them in its condensed consolidated financial statements. We licensed TEGSEDI and AKCEA-TTR-LRx from Ionis in April 2018. Prior to this date, Ionis had been advancing these medicines in development and incurring the expenses for those activities. Under our license agreements with Ionis, Ionis continues to conduct certain development, regulatory and manufacturing activities for our medicines and charges us for this work. As of June 30, 2020, Ionis owned approximately 76 percent of our outstanding stock. As a result, we are controlled by Ionis and are a "controlled company" under the marketplace rules of the Nasdaq Stock Market, or Nasdaq.

Critical Accounting Policies

The accounting policies we followed in the preparation of our interim condensed consolidated financial statements appearing at the beginning of this Quarterly Report on Form 10-Q are consistent in all material respects with those included in Note 2 of our Annual Report on the Form 10-K for the fiscal year ended on December 31, 2019 and Note 2 in our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Results of Operations

In order to analyze and compare our results of operations to other similar companies, we believe it is important to exclude non-cash stock-based compensation expense related to equity awards from our expenses. We believe non-cash stock-based compensation expense is not indicative of our operating results or cash flows from our operations. Further, we internally evaluate the performance of our operations excluding stock-based compensation. All numbers presented below exclude stock-based compensation expense unless otherwise indicated.

Comparison of the three months ended June 30, 2020 and 2019

Revenue


The following table sets forth our revenue for the periods presented (in
thousands):



                                                       Three Months Ended
                                                            June 30,
                                                        2020          2019
Product revenue, net                                 $   16,364     $  9,865
Licensing revenue                                             -        6,036

Research and development and license revenue under

  collaborative agreements                                6,013       10,722
Total revenue                                        $   22,377     $ 26,623



Product revenue. For the three months ended June 30, 2020, we recognized $16.4 million of product revenue from the sales of TEGSEDI in the U.S. and E.U. and sales of WAYLIVRA in the E.U. For the three months ended June 30, 2019, we recognized $9.9 million of product revenue from the sales of TEGSEDI in the U.S. and E.U.

Licensing revenue. For the three months ended June 30, 2020, we did not recognize any licensing revenue. For the three months ended June 30, 2019, we recognized $6.0 million of licensing revenue from PTC Therapeutics pursuant to our PTC License Agreement entered into in August 2018. This revenue was recognized in connection with obtaining regulatory approval for WAYLIVRA from the European Commission, or EC, in May 2019.

Research and development and license revenue. For the three months ended June 30, 2020, we recognized $6.0 million of research and development and license revenue primarily from our collaboration with Pfizer for vupanorsen. For the three months ended June 30, 2019, we recognized $10.7 million of research and development and license revenue related to our collaboration with Novartis for the AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx programs.


                                       32

--------------------------------------------------------------------------------

Cost of sales and license expense

The following table sets forth our cost of sales and license expense for the periods presented (in thousands):



                                                  Three Months Ended
                                                       June 30,
                                                   2020          2019
Cost of sales - product                         $    3,278      $ 1,227

Cost of sales - intangible asset amortization 1,418 1,419 Cost of license

                                          -        3,000

Total cost of sales, excluding non-cash

  stock-based compensation expense                   4,696        5,646
Non-cash stock-based compensation expense              350          137
Total cost of sales                             $    5,046      $ 5,783



Cost of sales - product. Product cost of sales was $3.3 million for the three months ended June 30, 2020, compared to $1.2 million for three months ended June 30, 2019, and consisted of period costs and certain fixed costs related to the sales of TEGSEDI and WAYLIVRA. We expense costs associated with the manufacture of our products as research and development expense prior to regulatory approval. Consequently, certain product costs of TEGSEDI and WAYLIVRA sold during the three months ended June 30, 2020 and 2019 were incurred prior to the regulatory approval for these products and therefore were not included in cost of sales during these periods. We expect cost of sales to increase as we deplete inventories that were previously expensed prior to regulatory approval. The cost of units sold during the period for which there was no cost basis was $0.4 million for the three months ended June 30, 2020 and $0.2 million for the three months ended June 30, 2019. All amounts described exclude non-cash compensation expense related to equity awards.

Cost of sales - intangible asset amortization. For each of the three months ended June 30, 2020 and 2019, intangible asset amortization was $1.4 million and consisted of amortization of intangible assets recorded as a result of the achievement of TEGSEDI regulatory milestones in the U.S. and E.U.

Cost of license. We did not incur any cost of license expense for the three months ended June 30, 2020. We incurred $3.0 million of cost of license related to a sub-license fee due to Ionis for the three months ended June 30, 2019 as a result of a milestone payment we earned under our license agreement with PTC Therapeutics.

Research and development expense

The following table sets forth our research and development expenses for the periods presented (in thousands):



                                                                Three Months Ended
                                                                     June 30,
                                                                 2020          2019
External TEGSEDI expenses                                     $    1,999     $    820
External WAYLIVRA expenses                                         2,498        3,806

Loss share under TTR license agreement with Ionis

  Pharmaceuticals                                                  2,244        1,204

Other external research and development projects expenses 11,150 5,487 Research and development personnel and overhead expenses

           8,356        6,391

Total research and development expenses, excluding non-cash

  stock-based compensation expense                                26,247       17,708
Non-cash stock-based compensation expense                          3,484        2,563
Total research and development expenses                       $   29,731     $ 20,271




Research and development expenses were $26.2 million for the three months ended June 30, 2020 compared to $17.7 million for the same period in 2019. The increase in research and development expenses was primarily due to the acquisition of API in 2020 for vupanorsen to fulfill Pfizer's exercised option to purchase additional vupanorsen and for the investment in AKCEA-APOCIII-LRx, and an increase in development activities related to AKCEA-TTR-LRx. These increases were partially offset by a decrease in development activities related to vupanorsen, WAYLIVRA and AKCEA-APOCIII-LRx. All amounts described exclude non-cash compensation expense related to equity awards.


                                       33

--------------------------------------------------------------------------------

Selling, general and administrative expense

The following table sets forth our selling, general and administrative expenses for the periods presented (in thousands):



                                                       Three Months Ended
                                                            June 30,
                                                        2020          2019

Selling, general and administrative expenses $ 29,852 $ 39,077 Non-cash stock-based compensation expense

                12,287       11,663

Total selling, general and administrative expenses $ 42,139 $ 50,740

Selling, general and administrative expenses were $29.9 million for the three months ended June 30, 2020 compared to $39.1 million for the three months ended June 30, 2019. Our selling, general and administrative expenses decreased primarily due to the impact of the COVID-19 Pandemic and timing of commercial launch activities. All amounts described exclude non-cash compensation expense related to equity awards.

Net Loss Share

In accordance with the TTR License Agreement with Ionis, we share the net profit/loss related to TEGSEDI commercial activities. As we are the principal for all commercial activities, we record on a gross basis in the condensed consolidated statements of operations based on the nature of the activity, including revenues, cost of products sold and sales and marketing expenses. Ionis' share of the net profit/loss is separately presented in the condensed consolidated statements of operations on the line titled "Net loss share from commercial activities under arrangement with Ionis Pharmaceuticals, Inc." Since TEGSEDI commercial activities are currently generating a loss, this represents the amount Ionis owes us under the licensing agreement for their share of the net loss of TEGSEDI commercial activities during the period. For the three months ended June 30, 2020 and 2019, we recorded $3.4 million and $11.5 million of net loss share, respectively. This decrease in net loss share is due to an increase in product revenue for TEGSEDI and decrease in selling, general and administrative expenses as described above.

Other income and expense

Investment income. Investment income for the three months ended June 30, 2020 totaled $1.1 million compared to $1.6 million for the same period in 2019. The decrease in investment income was primarily due to lower interest rates on investments in high quality corporate debt and U.S. government agencies during 2020 compared to 2019.

Income tax benefit (expense)

We recorded an income tax benefit of $0.6 million for the three months ended June 30, 2020 compared to income tax expense of $0.2 million for the same period in 2019. The decrease in our income tax expense was primarily due to a reversal of tax expense recorded for the three months ended March 31, 2020 related to a decrease in estimated 2020 tax liability.

Net Loss and Net Loss Per Share

Net loss for the three months ended June 30, 2020 was $49.6 million compared to a net loss of $37.3 million for the same period in 2019. The increase in net loss was primarily due to the decreases in research and development and license revenue and licensing revenue and increase in research and development expense described above. This increase in net loss was partially offset by the increase in product revenue and a decrease in selling, general and administrative expenses described above. Basic and diluted net loss per common share owned by Ionis and owned by others for the three months ended June 30, 2020 were both $0.49. Basic and diluted net loss per common share owned by Ionis and owned by others for the three months ended June 30, 2019 were both $0.40.


                                       34

--------------------------------------------------------------------------------

Comparison of the six months ended June 30, 2020 and 2019

Revenue


The following table sets forth our revenue for the periods presented (in
thousands):



                                                        Six Months Ended
                                                            June 30,
                                                       2020         2019
Product revenue, net                                 $ 31,523     $  16,619
Licensing revenue                                           -         6,036

Research and development and license revenue under

  collaborative agreements                              6,928       167,784
Total revenue                                        $ 38,451     $ 190,439



Product revenue. For the six months ended June 30, 2020, we recognized $31.5 million of product revenue from the sales of TEGSEDI in the U.S. and E.U. and sales of WAYLIVRA in the E.U. For the six months ended June 30, 2019, we recognized $16.6 million of product revenue from the sales of TEGSEDI in the U.S. and E.U.

Licensing revenue. For the six months ended June 30, 2020, we did not recognize any licensing revenue. For the six months ended June 30, 2019, we recognized $6.0 million of licensing revenue from PTC Therapeutics pursuant to our PTC License Agreement. This revenue was recognized in connection with obtaining regulatory approval for WAYLIVRA from the EC in May 2019.

Research and development and license revenue. For the six months ended June 30, 2020, we recognized $6.9 million of research and development and license revenue primarily from our collaboration with Pfizer for vupanorsen. For the six months ended June 30, 2019, we recognized $167.8 million of research and development and license revenue related to our collaboration with Novartis. The decrease in research and development revenue was primarily the result of the $150.0 million license fee we received in the first quarter of 2019 from Novartis upon exercise of its option to license AKCEA-APO(a)-LRx.

Cost of sales and license expense

The following table sets forth our cost of sales and license expense for the periods presented (in thousands):



                                                  Six Months Ended
                                                      June 30,
                                                  2020         2019
Cost of sales - product                         $   6,405     $ 2,150

Cost of sales - intangible asset amortization 2,837 2,822 Cost of license

                                         -       3,000

Total cost of sales, excluding non-cash

  stock-based compensation expense                  9,242       7,972
Non-cash stock-based compensation expense             587         255
Total cost of sales                             $   9,829     $ 8,227



Cost of sales - product. Product cost of sales was $6.4 million for the six months ended June 30, 2020, compared to $2.2 million for the six months ended June 30, 2019, and consisted of period costs and certain fixed costs related to the sales of TEGSEDI and WAYLIVRA. We expense costs associated with the manufacture of our products as research and development expense prior to regulatory approval. Consequently, certain product costs of TEGSEDI and WAYLIVRA sold during the six months ended June 30, 2020 and 2019 were incurred prior to the regulatory approval for these products and therefore were not included in cost of sales during these periods. We expect cost of sales to increase as we deplete inventories that were previously expensed prior to regulatory approval. The cost of units sold during the period for which there was no cost basis was $1.0 million for the six months ended June 30, 2020 and $0.3 million for the six months ended June 30, 2019. All amounts described exclude non-cash compensation expense related to equity awards.

Cost of sales - intangible asset amortization. For each of the six months ended June 30, 2020 and 2019, intangible asset amortization was $2.8 million and consisted of amortization of intangible assets recorded as a result of the achievement of TEGSEDI regulatory milestones in the U.S. and E.U.


                                       35

--------------------------------------------------------------------------------

Cost of license. We did not incur any cost of license for the six months ended June 30, 2020. We incurred $3.0 million for cost of license related to a sub-license fee due to Ionis for the six months ended June 30, 2019 as a result of a milestone payment earned as part of the license agreement with PTC Therapeutics.

Research and development expense

The following table sets forth our research and development expenses for the periods presented (in thousands):



                                                                 Six Months Ended
                                                                     June 30,
                                                                2020         2019
External TEGSEDI expenses                                     $  4,102     $   3,647
External WAYLIVRA expenses                                       3,623         6,093

Loss share under TTR license agreement with Ionis

  Pharmaceuticals                                                3,418           408

Other external research and development projects expenses 13,217 12,503 Research and development personnel and overhead expenses 17,893 15,755 Sublicensing expenses

                                                -        75,000

Total research and development expenses, excluding non-cash

  stock-based compensation expense                              42,253       113,406
Non-cash stock-based compensation expense                        4,833         6,484
Total research and development expenses                       $ 47,086     $ 119,890




Research and development expenses were $42.3 million for the six months ended June 30, 2020 compared to $113.4 million for the same period in 2019. The decrease in research and development expenses was primarily due to sublicensing expense of $75.0 million due to Ionis related to the Novartis option exercise for AKCEA-APO(a)-LRx in the first quarter of 2019 and a decrease in development activities related to vupanorsen, WAYLIVRA and AKCEA-APOCIII-LRx. This was offset by the acquisition of API for vupanorsen to fulfill Pfizer's exercised option to purchase additional vupanorsen and for the investment in AKCEA-APOCIII-LRx in the second quarter of 2020, as well as an increase in development activities related to AKCEA-TTR-LRx. All amounts described exclude non-cash compensation expense related to equity awards.

Non-cash stock-based compensation expense decreased for the six months ended June 30, 2020 compared to the six months ended June 30, 2019 due to an increase in estimated forfeitures.

Selling, general and administrative expense

The following table sets forth our selling, general and administrative expenses for the periods presented (in thousands):



                                                       Six Months Ended
                                                           June 30,
                                                       2020         2019

Selling, general and administrative expenses $ 70,403 $ 69,158 Non-cash stock-based compensation expense

              17,982       26,184

Total selling, general and administrative expenses $ 88,385 $ 95,342

Selling, general and administrative expenses were $70.4 million for the six months ended June 30, 2020 compared to $69.2 million for the six months ended June 30, 2019. Our selling, general and administrative expenses remained relatively consistent. In the first quarter of 2020, we increased our level of commercialization activities to continue to increase the presence of TEGSEDI in the U.S., E.U. and Canada, and WAYLIVRA in the E.U. Selling, general and administrative expenses decreased in the second quarter of 2020 primarily a result of the COVID-19 Pandemic and timing of commercial launch activities, which mostly offset the increase in expenses in the first quarter of 2020 compared to 2019. All amounts described exclude non-cash compensation expense related to equity awards.

Non-cash stock-based compensation expense decreased for the six months ended June 30, 2020 compared to the six months ended June 30, 2019 due to the departures of certain members of senior management and certain members of our board of directors, as well as an increase in our forfeiture rate estimates.


                                       36

--------------------------------------------------------------------------------

Net Loss Share

In accordance with the TTR License Agreement with Ionis, we share the net profit/loss related to TEGSEDI commercial activities. As we are the principal for all commercial activities, we record on a gross basis in the condensed consolidated statements of operations based on the nature of the activity, including revenues, cost of products sold and sales and marketing expenses. Ionis' share of the net profit/loss is separately presented in the condensed consolidated statements of operations on the line titled "Net loss share from commercial activities under arrangement with Ionis Pharmaceuticals, Inc." Since TEGSEDI commercial activities are currently generating a loss, this represents the amount Ionis owes us under the licensing agreement for their share of the net loss of TEGSEDI commercial activities during the period. For the six months ended June 30, 2020 and 2019, we recorded $10.5 million and $20.5 million of net loss share, respectively. This decrease in net loss share is due to an increase in product revenue for TEGSEDI and decrease in selling, general and administrative expenses as described above.

Other income and other expense

Investment income. Investment income for the six months ended June 30, 2020 and 2019 both totaled $2.8 million. Investment income remained consistent primarily due to a higher average investment balance which was offset by lower interest rates on investments in high quality corporate debt and U.S. government agencies investments during 2020 compared to 2019.

Income tax benefit (expense)

We recorded an income tax benefit of $1.4 million for the six months ended June 30, 2020 compared to income tax expense of $0.3 million for the same period in 2019. We recorded an income tax benefit for the six months ended June 30, 2020 primarily due to the tax benefit of $1.7 million related to the Coronavirus, Aid, Relief and Economic Security Act, or CARES Act, signed into law on March 27, 2020, which was partially offset by income tax expense related to taxable income earned in certain foreign jurisdictions.

Under the Tax Cut and Jobs Act of 2017, or the Tax Act, federal net operating losses incurred in 2018 and in future years could be carried forward indefinitely, but the deductibility of such federal net operating losses was limited. The CARES Act temporarily removes the limitation on net operating loss deductions, resulting in the $1.7 million tax benefit. The limitation on the deductibility of federal net operating losses is reinstated for tax years beginning after 2020.

Net Loss and Net Loss Per Share

Net loss for the six months ended June 30, 2020 was $92.4 million compared to net loss of $10.1 million for the same period in 2019. This increase in net loss was primarily due to the $150.0 million license fee we received from Novartis in 2019 related to Novartis' exercise of its option to license AKCEA-APO(a)- LRx of which $75.0 million was net of the sublicense fee due to Ionis. A similar transaction did not occur in 2020. Basic and diluted net loss per common share owned by Ionis and owned by others for the six months ended June 30, 2020 were both $0.91. Basic and diluted net loss per common share owned by Ionis and owned by others for the six months ended June 30, 2019 was $0.06 and $0.26, respectively.

Liquidity and Capital Resources

At June 30, 2020 we had cash, cash equivalents and investments of $389.9 million and an accumulated deficit of $573.7 million compared to cash, cash equivalents and investments of $463.7 million and an accumulated deficit of $481.3 million at December 31, 2019.

At June 30, 2020, we had working capital of $393.0 million compared to working capital of $454.9 million at December 31, 2019. Working capital decreased in 2020 primarily due to a decrease in cash used for operating activities. As of June 30, 2020, our payable to Ionis under our agreements was $5.3 million.

In February 2019, we earned a license fee of $150.0 million related to Novartis' option exercise of AKCEA-APO(a)-LRx, of which we owed Ionis $75.0 million as a sublicense fee that we settled through the issuance of 2,837,373 shares of our common stock in March 2019. See Note 4, Revenue from Collaboration and License Agreements, and Note 9, License Agreements and Services Agreement with Ionis, to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for more information about our collaboration with Novartis and Cardiometabolic License Agreement with Ionis.

In October 2019, we entered into an agreement with Pfizer for the development and commercialization of vupanorsen as discussed in Note 4, Revenue from Collaboration and License Agreements. As a result, we received a license fee of $250.0 million in November 2019 we issued 6,873,344 shares of our common stock to Ionis as payment of the related $125.0 million sublicense fee.


                                       37

--------------------------------------------------------------------------------

TEGSEDI is approved in the U.S., E.U., Canada and Brazil and we are continuing our commercialization efforts in these regions. We began to generate product revenue from TEGSEDI sales in the fourth quarter of 2018. WAYLIVRA is approved in the E.U. and we are advancing our commercialization efforts in that region. We began to generate product revenue from WAYLIVRA sales in the third quarter of 2019.

We anticipate that we will continue to incur losses for the foreseeable future, and losses may continue to increase as we develop, seek regulatory approval for, and begin to commercialize our other pipeline medicines. We are subject to all of the risks incident in developing and commercializing new medicines and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

Future Funding Requirements

We expect that our cash, cash equivalents and investments of $389.9 million as of June 30, 2020, together with cash expected to be generated from sales of TEGSEDI and WAYLIVRA, will be sufficient to fund our operations through at least the next 12 months from the issuance of this Quarterly Report on Form 10-Q. Until such time, if ever, as we can generate substantial revenue, we may finance our cash needs through additional financing in the future including, but not limited to, through the issuance of our common stock, other equity or debt financings or collaborations or partnerships with other companies. In any event, we may not generate significant revenue from product sales or our license and collaboration agreements prior to the use of our existing cash, cash equivalents and investments. We do not have any committed external sources of funds. We cannot provide assurances that financing will be available when and as needed, particularly if the COVID-19 Pandemic continues to disrupt global financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity, or that, if available, the financings will be on favorable or acceptable terms. If we are unable to obtain additional financing when and if we require it, this could have a material adverse effect on our business and results of operations. To the extent we issue additional equity securities, our existing stockholders could experience a dilution of their ownership and such dilution could be substantial.

Our forecast of the period of time through which our financial resources will be adequate to support our operations involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong and we could use our available capital resources sooner than we currently expect. The amount and timing of future funding requirements, both near- and long-term, will depend on many factors, including, but not limited to:

    •   the design, initiation, progress, size, timing, costs and results of our
        clinical and nonclinical studies;


    •   the outcome, timing and cost of regulatory approvals by the FDA and
        comparable foreign regulatory authorities, including the potential for the
        FDA or comparable foreign regulatory authorities to require that we
        perform more studies than, or evaluate clinical endpoints other than,
        those that we currently expect;


    •   other potential delays in commercializing or marketing our products
        related to the COVID-19 Pandemic, including delays in receiving regulatory
        approvals by the FDA and comparable foreign regulatory authorities, delays
        in necessary interactions with local and foreign regulators, ethics
        committees and other important agencies and contractors due to limitations
        in employee resources or forced furlough of government employees, or
        refusals to accept data from clinical trials conducted in affected
        geographies;


  • the number and characteristics of medicines that we may pursue;


    •   our need to expand our development activities, including our need and
        ability to hire additional employees;


  • the effect of competing technological and market developments;


    •   the cost of establishing sales, marketing, manufacturing and distribution
        capabilities for our medicines;


    •   our strategic collaborators' success in developing and commercializing our
        medicines;


    •   our need to add infrastructure, implement internal systems and hire
        additional employees to operate as a public company; and


    •   the revenue, if any, generated from commercial sales of our medicines for
        which we receive marketing authorization, which may be affected by market
        conditions, including obtaining coverage and adequate reimbursement of our
        medicines from third-party payers, including government programs and
        managed care organizations, and competition within the therapeutic class
        to which our medicines are assigned.

If we cannot expand our operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition and results of operations could be materially adversely affected.


                                       38

--------------------------------------------------------------------------------

Contractual Obligations and Commitments

There were no material changes to our contractual obligations and commitments described under Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the SEC on March 2, 2020.

Recently Issued Accounting Pronouncements

We describe the recently issued accounting pronouncements that apply to us in Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Off-balance Sheet Arrangements

We did not have any off-balance sheet arrangements during the period presented, as defined in the rules and regulations of the SEC.


                                       39

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses

share with twitter share with LinkedIn share with facebook
All news about AKCEA THERAPEUTICS, INC.
08/05AKCEA THERAPEUTICS : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION..
AQ
08/04AKCEA THERAPEUTICS : 2Q Earnings Snapshot
AQ
08/04AKCEA THERAPEUTICS, INC. : Results of Operations and Financial Condition, Financ..
AQ
08/04AKCEA THERAPEUTICS : Reports Financial Results and Highlights for Second Quarter..
PR
07/23AKCEA THERAPEUTICS : Announces Approval for Reimbursement of TEGSEDI in Austria ..
AQ
07/22AKCEA THERAPEUTICS : Announces Approval for Reimbursement of TEGSEDI® (inotersen..
PR
07/21AKCEA THERAPEUTICS : Appoints New Senior Vice President, Global Medical Affairs
AQ
07/09AKCEA THERAPEUTICS, INC. : Change in Directors or Principal Officers, Entry into..
AQ
06/29AKCEA THERAPEUTICS : Appoints Tracy Palmer Berns as Chief Compliance Officer
PR
06/19AKCEA THERAPEUTICS, INC. : Change in Directors or Principal Officers (form 8-K)
AQ
More news
Financials (USD)
Sales 2020 108 M - -
Net income 2020 -194 M - -
Net cash 2020 384 M - -
P/E ratio 2020 -5,88x
Yield 2020 -
Capitalization 1 158 M 1 158 M -
EV / Sales 2020 7,16x
EV / Sales 2021 5,61x
Nbr of Employees 294
Free-Float 17,1%
Chart AKCEA THERAPEUTICS, INC.
Duration : Period :
Akcea Therapeutics, Inc. Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends AKCEA THERAPEUTICS, INC.
Short TermMid-TermLong Term
TrendsBearishBearishBearish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 5
Average target price 27,00 $
Last Close Price 11,11 $
Spread / Highest target 269%
Spread / Average Target 143%
Spread / Lowest Target 44,0%
EPS Revisions
Managers
NameTitle
Damien McDevitt Chief Executive Officer & Director
B. Lynne Parshall Chairman
Alex G. Howarth Chief Operating Officer
Michael Dennis Price Chief Financial Officer & Executive Vice President
William T. Andrews Chief Medical Officer
Sector and Competitors
1st jan.Capitalization (M$)
AKCEA THERAPEUTICS, INC.-32.70%1 158
JOHNSON & JOHNSON0.75%394 028
ROCHE HOLDING AG1.08%297 694
PFIZER, INC.-2.17%212 995
MERCK & CO., INC.-9.09%209 118
NOVARTIS AG-15.76%187 147