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Genentech Provides an Update on Phase III Study of Tecentriq in People With Muscle-invasive Urothelial Cancer

On January 24, 2020 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the Phase III IMvigor010 study evaluating Tecentriq (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC) (Press release, Genentech, JAN 24, 2020, View Source [SID1234553471]). Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.

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"Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers."

The goal in treating MIUC early is to reduce the risk of the disease recurring or spreading to other parts of the body. More treatment options following surgery are needed as approximately half of people with MIUC will develop a recurrence of their disease within two years of surgery.

In addition to ongoing Phase III studies in early and advanced bladder cancer, Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMvigor010 study

IMvigor010 is a global Phase III, open-label, randomized, controlled study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq compared with observation in 809 people with MIUC, who are at high risk for recurrence following resection. The primary endpoint is DFS as assessed by investigator, which is defined as the time from randomization to invasive urothelial cancer recurrence or death.

About bladder cancer

According to the American Cancer Society (ACS), it is estimated that more than 81,000 Americans will be diagnosed with bladder cancer in 2020. Urothelial cancer is the most common type of bladder cancer, accounting for about 90-95% of all cases. MIUC is a type of urothelial cancer that has spread into the muscle wall of the bladder, ureter, or renal pelvis. Approximately 25% of people newly diagnosed with bladder cancer are diagnosed with muscle-invasive disease, which is associated with a poorer prognosis than non-MIUC.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Bladder Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma. Tecentriq may be used when your bladder cancer:

has spread or cannot be removed by surgery, and if you have any one of the following conditions:
you are not able to take chemotherapy that contains a medicine called cisplatin, and your cancer tests positive for "PD-L1", or
you are not able to take chemotherapy that contains any platinum regardless of the levels of "PD-L1" status, or
you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

It is not known if Tecentriq is safe and effective in children.

Important Safety Information
What is the most important information about Tecentriq?
Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Tecentriq can cause serious side effects, including:

Lung problems (pneumonitis)–signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain
Liver problems (hepatitis)–signs and symptoms of hepatitis may include yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual
Intestinal problems (colitis)–signs and symptoms of colitis may include diarrhea (loose stools) or more bowel movements than usual, blood or mucus in stools or dark, tarry, sticky stools, and severe stomach area (abdomen) pain or tenderness
Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary)–signs and symptoms that the hormone glands are not working properly may include headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, the voice gets deeper, urinating more often than usual, nausea or vomiting, and stomach area (abdomen) pain
Problems in other organs–signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
Severe infections–signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating, and frequent urination or back pain
Severe infusion reactions–signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of the face or lips, dizziness, fever, feeling like passing out, and back or neck pain
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome); or are being treated for an infection
are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

feeling tired or weak
nausea
cough
shortness of breath
decreased appetite
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

Report side effects to the FDA at 1-800-FDA-1088 or View Source
Report side effects to Genentech at 1-888-835-2555.

Please visit View Source for the Tecentriq full Prescribing Information for additional Important Safety Information.

About Genentech in personalized cancer immunotherapy

For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 10 cancer immunotherapy medicines across 70 clinical trials alone or in combination with other medicines. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit View Source

Entry into a Material Definitive Agreement.

On January 23, 2020, Genprex, Inc. (the "Company") reported that it has entered into a securities purchase agreement (the "Securities Purchase Agreement") with four institutional accredited investors identified on the signature page thereto (the "Purchasers") pursuant to which the Company agreed to issue and sell to the Purchasers an aggregate of 7,620,000 shares (the "Shares") of its common stock, par value $0.001 per share (the "Common Stock"), in a registered direct offering (the "Registered Direct Offering") (Filing, 8-K, Genprex, JAN 23, 2020, View Source [SID1234553528]). The Shares were offered by the Company pursuant to its shelf registration statement on Form S-3 (File No. 333-233774) filed with the Securities and Exchange Commission (the "Commission") on September 16, 2019, as amended on October 4, 2019 (as amended, the "Registration Statement") and declared effective on October 28, 2019.

The purchase price for one Share in the Registered Direct Offering was $1.05. The closing of the Registered Direct Offering is anticipated to occur on January 27, 2020, subject to customary closing conditions. The Company expects the aggregate net proceeds from the Offerings, after deducting estimated offering expenses, to be approximately $7.2 million. The Company intends to use the aggregate net proceeds for working capital and other general corporate purposes.

The Securities Purchase Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing.

The foregoing description of the material terms of the Securities Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Securities Purchase Agreement, a copy of which is filed herewith as Exhibit 10.1 and is incorporated herein by reference.

The representations, warranties and covenants contained in the Securities Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to the Securities Purchase Agreement and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Securities Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Securities Purchase Agreement and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Commission.

The legal opinion, including the related consent, of Sheppard, Mullin, Richter & Hampton LLP relating to the issuance and sale of the Shares is filed as Exhibit 5.1 hereto.

In connection with the Registered Direct Offering, the Company entered into a Placement Agency Agreement with registered broker-dealers (the "Placement Agents"), pursuant to which the Company paid an aggregate cash fee of $640,080 to the Placement Agents (eight percent (8.0%) of gross proceeds from the Registered Direct Offering). The Company will also reimburse the Placement Agents for their expenses incurred by them in connection with the Registered Direct Offering.

The foregoing description of the material terms of the Placement Agency Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Placement Agency Agreement, a copy of which is filed herewith as Exhibit 1.1 and is incorporated herein by reference.

This Current Report on Form 8-K does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Luminex Corporation To Release Fourth Quarter and Full-Year 2019 Results After Market Close On February 10, 2020

On January 23, 2020 Luminex Corporation (NASDAQ: LMNX) reported that it plans to report results for the fourth quarter and full-year ended December 31, 2019 on Monday, February 10, 2020 after the market close (Press release, Luminex, JAN 23, 2020, View Source [SID1234553476]).

The company will host a conference call that day at 5:00 p.m. Eastern Time to discuss operating highlights and financial results.

The conference call will be webcast live and may be accessed at Luminex’s Investor Relations website at investor.luminexcorp.com. The presentation slides will be posted to our Investor Relations website after the market close on February 10, 2020. Analysts may participate on the conference call by dialing (877) 930-7053 (U.S.) or (253) 336-7290 (outside the U.S.). The access code is 1593082. The webcast will be archived for six months on our website using the ‘replay’ link.

CStone successfully hosted the first U.S. R&D Day in New York

On January 23, 2020 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that it successfully hosted its 2020 U.S. R&D Day in New York on January 21 (Press release, CStone Pharmaceauticals, JAN 23, 2020, View Source [SID1234553474]). CStone’s management team highlighted major milestones the Company had achieved in research, clinical development, business development and commercialization strategies since its establishment. The management team also provided updates on the progress of the Company’s pipeline. Leading academics and key opinion leaders from China and the United States provided insights on the latest trends in the transformation of cancer treatments in China.

Targeting five indications, CStone plans to submit five NDAs in 2020 for CS1001, an anti-PD-L1 monoclonal antibody; pralsetinib, a RET inhibitor; and AYVAKITTM (avapritinib), a KIT and PDGFRA inhibitor, in Mainland China and Taiwan. The Company plans to release the top-line data from seven ongoing clinical trials of these three drug candidates. CStone will focus on developing and commercializing innovative immuno-oncology therapies and precision medicines to address the unmet needs in cancer treatment in China and globally, and drive its Pipeline 2.0 strategy to accelerate its transition toward a commercial-stage biopharmaceutical company with a unique and efficient R&D platform. Moreover, the Company plans to submit NDAs for around 10 indications for four products in the next two to three years.

"China’s biopharmaceutical industry is undergoing significant transformation, and CStone is at the forefront of this paradigm shift. With a strategy focused on large cancer indications in China, unmet patient needs, and combination therapies, we are currently conducting over 30 clinical trials, including 13 registrational studies, and 14 combination trials," said Dr. Frank Jiang, Chairman and CEO of CStone. "We are very pleased that Shirley Zhao has joined us as General Manager for Greater China and Head of Commercial Operations, at this inflection point in CStone’s transition from clinical-stage to commercial-stage. In the next two to three years, Shirley will lead the establishment of CStone’s commercialization capabilities and the launch of multiple innovative products in the Greater China region. Leveraging our unique and highly efficient early-stage clinical development platform, we will continue to strengthen our pipeline and drive biopharmaceutical innovations in China."

Event highlights:

CStone’s achievements

CStone has established a clinical development-driven business model and built a world-class clinical team with significant experience in translational medicine and clinical development. In addition, the Scientific Advisory Board comprised of four internationally renowned immuno-oncologists has substantially strengthened the Company’s R&D capabilities in immunotherapies and precision medicines, further enhancing and optimizing CStone’s R&D strategies and product pipeline.
CStone has built a risk-balanced and highly competitive immunotherapy-focused pipeline. Among the Company’s 15 cancer drug candidates, five are in pivotal late-stage clinical development. AYVAKITTM (avapritinib), developed by Blueprint Medicines, and TIBSOVO (ivosidenib), developed by Agios Pharmaceuticals have received NDA approvals from the U.S. FDA.
Among these trials, the clinical studies of CS1001, an anti-PD-L1 monoclonal antibody, have achieved promising clinical results with patients treated with CS1001 exceeding one thousand. In 2019, CStone released encouraging data from the trials of CS1001 in esophageal carcinoma and a number of other large cancer indications in China at major medical conferences, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the Chinese Society of Clinical Oncology (CSCO), and the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meetings.
The two in-licensed products of CStone’s pipeline candidates that have received NDA approvals from the U.S. FDA are AYVAKITTM (avapritinib), developed by the partner company, Blueprint Medicines, and TIBSOVO (ivosidenib), developed by Agios Pharmaceuticals. Moreover, Blueprint Medicine has initiated a rolling NDA submission to the U.S. FDA for pralsetinib. All three candidate drugs are being investigated in multiple registrational trials in China.
In December, 2019, the global Phase III VOYAGER trial of avapritinib in third-line gastrointestinal stromal tumors (GIST), and the global Phase I/II ARROW study of pralsetinib in second- and later-line non-small cell lung cancer (NSCLC) have both completed their targeted enrollments of Chinese patients ahead of schedule.
CStone developed comprehensive early-stage programs and is scaling up its combination therapy-focused pipeline. The Company has made significant progress with two of its backbone immunotherapy assets, CS1002, an anti-CTLA-4 monoclonal antibody; and CS1003, an anti-PD-1 monoclonal antibody. Both assets generated promising results as monotherapies in Phase I studies, and CS1003 has already entered a global Phase III registrational trial. In the development of combination therapies, CStone recently initiated multiple combination trials and will continue to advance these combination studies in 2020.
Leveraging a unique and highly efficient R&D platform and an innovation ecosystem, CStone has further strengthened its Pipeline 2.0. The Company will continue to develop first-in-class and best-in-class drugs and therapies to maintain its lead in innovations.
In 2019, CStone advanced two drug candidates in its pipeline into clinical development, and commenced a dozen preclinical research initiatives.
Major milestones expected in 2020 include:

One New Drug Application approval
TIBSOVO, for the treatment of R/R AML, is expected to receive an NDA approval in Taiwan and become CStone’s first commercialized product in the Greater China region.
5 NDA submissions
CStone plans to submit five new drug applications in Mainland China and Taiwan, for CS1001, pralsetinib, and avapritinib.
Seven clinical trial data releases
CStone plans to release top-line data from seven clinical trials of CS1001 (an anti-PD-L1 monoclonal antibody), pralsetinib, and avapritinib, and six of these trials are registrational studies.
Development strategies for 2020

To consolidate resources to focus on the delivery of the 13 milestones.
CStone will build a commercial organization for Greater China equipped with core commercialization capabilities to enable the Company’s successful transition to the commercial-stage.
CStone will continue to seek strategic collaborations with key players, to drive the future growth of the company.
Leveraging its internal R&D, CStone will transition into its Pipeline 2.0 and drive the sustained growth of the Company. In the next three to five years, CStone will add first-in-class and best-in-class multi-specific monoclonal antibodies and molecular backbone assets to its pipeline. The Company plans to further explore tumor microenvironment modulators, cancer vaccines, new pathway inhibitors, and innovative combination approaches that could potentially bolster the effect of anti-PD-(L)1 antibodies.
New product launches

In the next two to three years, CStone plans to launch four of its drug candidates, including avapritinib, pralsetinib, ivosidenib and the anti-PD-L1 monoclonal antibody CS1001, in the Greater China region, targeting a total of 10 cancer indications.
Key messages from KOL speakers

Dr. Paul Bunn, MD, former President of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and Distinguished Professor at University of Colorado Cancer Center, commented that latest clinical data of the RET inhibitor pralsetinib were very encouraging. The trial has already completed the patient target enrollment, which included naïve patients and patients who have received platinum-based chemotherapy. He expects this precision medicine will benefit cancer patients in the future.
Dr. Eytan Stein, MD, Professor at the Memorial Sloan Kettering Cancer Center, commented that compared to current standard chemotherapies, ivosidenib could bring significant clinical benefits to AML patients and its high-selectivity could broaden clinical benefits to cancer patients with an IDH1-mutation.
Dr. Yilong Wu, MD, President of the Chinese Thoracic Oncology Group (C-TONG), past president of Chinese Society of Clinical Oncology (CSCO), tenured professor of Guangdong Provincial People’s Hospital and Guangdong Lung Cancer Research Institute, emphasized that CStone has initiated three registrational lung cancer trials and the Company will play an important role in the lung cancer field in China.
– CS1001 is currently being investigated in the Phase III GEMSTONE-301 study in patients with locally advanced or unresectable NSCLC, and it could potentially benefit a wide range of patients. Considering the clinical practices in China, the trial also included patients who had received either concomitant or sequential radiochemotherapy. In addition, CS1001 is also being investigated in a Phase III trial in first-line Stage IV NSCLC.
– The study of pralsetinib in RET-fusion NSCLC has demonstrated promising clinical utility. Due to the persistent high incident rate of lung cancers and the lack of any effective treatment for RET-mutant cancers, pralsetinib has the potential of effectively addressing the current treatment gap in RET-fusion NSCLC in China.
Dr. Jian Li, MD, Professor at Beijing Cancer Hospital and Chairman-elect of the Chinese Society of Clinical Oncology’s (CSCO) Committee on GIST, acknowledged avapritinib’s therapeutic promise in the treatment of GIST in China. Avapritinib is a first-in-class precision medicine approved by the U.S. FDA for the treatment of GIST, and there is currently no effective treatment for PDGFRA D842V mutant GIST in China. Available clinical data of avapritinib in PDGFRA exon 18 mutant GIST (including PDGFRA D842V mutations) have demonstrated compelling antitumor activity and a more tolerable safety profile. The drug could significantly benefit GIST patients who are in need of effective treatment options.
Dr. Weiping Zou, MD, PhD, Professor at University of Michigan, Director of the Center of Excellence for Cancer Immunology and Immunotherapy, and Chair of the American Association of Cancer Research’s (AACR) (Free AACR Whitepaper) Cancer Immunology Working Group (CIMM), commented that CStone has made significant progress in the past three years, and he will likely to further collaborate with the Company in selecting Class I drug targets for future development and he looks forward to facilitating CStone’s transition to Pipeline 2.0.

eHealth, Inc. Announces Preliminary Results for the Fourth Quarter and Fiscal Year 2019

On January 23, 2020 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance exchange in the United States, reported preliminary, unaudited financial results and select operating metrics for the fourth quarter and fiscal year ended December 31, 2019 (Press release, eHealthInsurance, JAN 23, 2020, View Source [SID1234553473]).

"I am proud of our achievements in 2019. After raising our guidance twice in the past year, we significantly exceeded our financial and operating targets driven by consistently strong execution throughout the year. 2019 culminated with an exceptional performance by our team during the fourth quarter Medicare annual enrollment period. Our marketing and business development organizations drove record consumer demand to the eHealth platform allowing us to grow fourth quarter approved Medicare members in excess of 85%," commented Scott Flanders, chief executive officer of eHealth. "We remain excited about the Medicare market opportunity and significant growth potential ahead of us and are looking forward to sharing our outlook for 2020 as part of our fourth quarter earnings release next month."

The preliminary, unaudited financial results and selected operating metrics included in this press release are based on information available as of January 23, 2020 and management’s initial review of operations for the fourth quarter and year ended December 31, 2019. They remain subject to change based on management’s ongoing review of the company’s fourth-quarter and full year results and are forward-looking statements. eHealth assumes no obligation to update these statements. The actual results may be materially different and are affected by the risk factors and uncertainties identified in this press release and in eHealth’s annual and quarterly filings with the Securities and Exchange Commission.

As part of the year-end closing process, the company is enhancing the manner in which it estimates residual or "tail" revenue from the company’s Medicare Advantage members approved in prior periods. Since the adoption of Accounting Standards Codification (ASC) 606, the company’s cash collections for Medicare Advantage policies have in general exceeded initial lifetime value estimates. This dynamic has contributed in past quarters to the recognition of increasing amounts of residual or "tail" revenue from Medicare members approved in prior periods. Our preliminary results exclude the positive impact of changes in estimates for expected collections for Medicare Advantage members approved since our adoption of ASC 606 through the third quarter of 2019. The company plans to include the results of any such changes in estimates as well as full financial and operating results as part of its fourth quarter and full year 2019 earnings release.

Fourth Quarter and Fiscal Year 2019 Preliminary Results

Excluding any positive impact from the changes in estimates to residual revenue for Medicare Advantage members approved since our adoption of ASC 606 through the third quarter of 2019, we expect the following fourth quarter and fiscal year 2019 results:

Revenue for the fourth quarter of 2019 is expected to be in the range of $257.5 to $259.5 million with expected fourth quarter revenue from the Medicare segment in the range of $239.0 to $240.5 million.
GAAP net income for the fourth quarter of 2019 is expected to be in the range of $53.0 to $55.0 million. Adjusted EBITDA(a) for the fourth quarter of 2019 is expected to be in the range of $98.5 to $100.5 million.
Revenue for the year ended December 31, 2019 is expected to be in the range of $462.0 to $464.0 million as compared to the company’s guidance of $365.0 to $385.0 million. Revenue from the Medicare segment for the full year 2019 is expected to be in the range of $403.5 to $405.0 million as compared to the company’s guidance of $318.0 to $333.0 million.
GAAP net income for the year ended December 31, 2019 is expected to be in the range of $31.0 to $33.0 million as compared to the company’s guidance of $20.9 to $25.9 million.
Adjusted EBITDA(a) for the year ended December 31, 2019 is expected to be in the range of $89.0 to $91.0 million as compared to the company’s guidance of $65.0 to $70.0 million.

Adjusted EBITDA is calculated by adding stock-based compensation expense, depreciation and amortization expense, change in fair value of earnout liability, amortization of intangible assets, other income, net of expenses and provision for income taxes to GAAP net income. See "Non-GAAP Financial Information Reconciliations."

Approved Members

The number of approved members for all Medicare products, which includes Medicare Advantage, Medicare Supplement and Medicare Part D Prescription Drug Plans, grew 88% during the fourth quarter of 2019 compared to the fourth quarter of 2018. The number of approved members for Medicare Advantage products grew 100% over the same time period. For the full year 2019, the number of approved members for all Medicare products grew 81% compared to the full year 2018 with approved members for Medicare Advantage products growing 88% over the same time period.

The number of approved members for major medical individual and family plan (IFP) products grew 1% during the fourth quarter of 2019 compared to the fourth quarter a year ago. For the full year 2019, the number of approved members for IFP products declined 25% compared to 2018. The decline in approved IFP members reflects weaker than expected enrollment activity in the overall individual and family health insurance market as well as our continuing emphasis on the Medicare business in allocating our marketing resources.