On May 11, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the first quarter ended March 31, 2020 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, MAY 11, 2020, View Source [SID1234557489]).

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"This has been a very exciting start to the year for Halozyme as we have achieved multiple value-creating events in our ENHANZE business, including U.S. FDA approval for DARZALEX FASPROTM with a broad set of label indications, and the receipt of a positive CHMP opinion in the EU, also recommending a broad set of label indications. The positive CHMP opinion is typically a precursor to marketing clearance," said Dr. Helen Torley, president and chief executive officer. "As we look ahead, we are excited about the launches of subcutaneous DARZALEX in the U.S. and E.U. as well as the potential FDA approval of the subcutaneous fixed-dose combination of Perjeta and Herceptin later this year, and what they may mean for patients."

"I want to express my gratitude to the Halozyme team, our partners and suppliers for our continued progress in spite of the challenges posed by COVID-19," continued Dr. Torley. "In light of these challenges, it is obviously difficult to predict how the pandemic recovery will unfold in the coming quarters. However, based on the latest information from our partners and suppliers, and our team’s commitment to maintaining a lean operating structure, we feel confident maintaining our 2020 financial guidance at this time."

First Quarter 2020 and Recent Highlights Include:

On May 1, the Company announced that The Janssen Pharmaceutical Companies of Johnson and Johnson received U.S. FDA approval of DARZALEX FASPROTM in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients. As a fixed-dose formulation, DARZALEX FASPROTM can be administered subcutaneously over three to five minutes, significantly less time than IV DARZALEX which requires multi-hour infusions.
On April 30, the Company announced that Janssen-Cilag International NV (Janssen) received a Committee for Medicinal Products for Human Use (CHMP) Positive Opinion from the European Medicines Agency (EMA) recommending approval of a DARZALEX (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings. The CHMP’s Positive Opinion for daratumumab SC formulation applies to multiple current daratumumab indications including newly diagnosed and transplant-ineligible patients, as well as relapsed or refractory patients.
In April, the Company announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) by Janssen Pharmaceutical K.K. (Janssen) seeking approval of a new subcutaneous (SC) formulation of daratumumab, an intravenous (IV) treatment approved for patients with multiple myeloma.
During the first quarter, the Company repurchased 3.2 million shares of its common stock at a weighted average price of $16.15 per share. These repurchased shares were in addition to shares repurchased as part of an Accelerated Share Repurchase plan that was completed in mid-February. To date the Company has repurchased over $250 million in shares as part of its three-year share repurchase authorization of up to $550 million approved by the Board in November 2019.
In February, the Company announced that the FDA has accepted a Biologics License Application (BLA) from Genentech, a member of the Roche Group, for the fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin ) for subcutaneous administration using ENHANZE technology in combination with IV chemotherapy for the treatment of eligible patients with HER2-positive breast cancer, with an action date of October 18, 2020.
First Quarter 2020 Financial Highlights

Revenue for the first quarter was $25.4 million compared to $56.9 million for the first quarter of 2019. The year-over-year decrease was primarily driven by a $30 million upfront payment from argenx in the prior year period. Revenue for the quarter included $16.8 million in royalties, which compared to $18.0 million in the prior year period.
Research and development expenses for the first quarter were $10.2 million, compared to $31.3 million for the first quarter of 2019. The decrease in expenses was due to a decrease in clinical trial activities-related costs as a result of the Company halting its oncology drug development efforts and related restructuring as announced in November 2019.
Selling, general and administrative expenses for the first quarter were $12.6 million, compared to $18.0 million for the first quarter of 2019. The decrease was due to lower compensation and commercial-related expenses related to the corporate restructuring announced in November 2019.
Net loss for the first quarter was $6.1 million, or $0.04 per share, compared to a net income in the first quarter of 2019 of $1.8 million, or $0.01 per share.
Cash, cash equivalents and marketable securities were $368.2 million at March 31, 2020, compared to $421.3 million at December 31, 2019.
Financial Outlook for 2020

The Company continues to monitor the impact of the COVID-19 pandemic on its business and receive updates from its partners and suppliers on how their businesses are affected. Based on this information and Halozyme’s planned expenditures for the year, the Company’s 2020 financial guidance remains unchanged from that first provided on January 14, 2020. For 2020 Halozyme continues to expect:

Revenues of $230 million to $245 million, representing growth of 17% to 25%;
Earnings per share on a GAAP basis of $0.60 to $0.75 with the first quarter of sustainable profitability beginning in Q2 2020.
The guidance on earnings per share does not reflect any potential impact from the Company’s plans to repurchase any additional number of shares, up to an additional $98 million worth, during the remainder of 2020. The amount and timing of shares repurchased during 2020 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.

Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2020 today, Monday, May 11, 2020 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (833) 968-2181 (domestic callers) or (825) 312-2108 (international callers). A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 3199114.

On May 11, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported the pricing of a public offering of $550 million aggregate principal amount of its 2.800% senior notes due 2031 under Quest Diagnostics’ shelf registration statement (Press release, Quest Diagnostics, MAY 11, 2020, View Source [SID1234557517]).

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Quest Diagnostics expects to receive the net offering proceeds upon closing on May 13, 2020, subject to customary closing conditions. The company intends to use the net proceeds from the offering for general corporate purposes, which may include the repayment of indebtedness. The indebtedness the company may repay with the net proceeds of the offering includes the company’s $550 million aggregate principal amount of 4.70% senior notes due 2021 and outstanding borrowings under the company’s senior unsecured revolving credit facility and secured receivables credit facility.

This press release shall not constitute an offer to sell or a solicitation of an offer to purchase any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. This offering may be made only by means of a prospectus supplement and accompanying base prospectus, copies of which or information concerning this offering may be obtained by calling Goldman Sachs & Co. LLC, collect at 1 (212) 902-1171, J.P. Morgan Securities LLC, collect at 1 (212) 834-4533 or Mizuho Securities USA LLC, toll-free at 1 (866) 271-7403.

On May 11, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of best-in-class bioproduction tools for cell and gene therapies, reported that the Company’s first quarter 2020 financial results will be released after market close on Thursday, May 14th, 2020, and that the Company will host a conference call and live webcast at 4:30 p.m. ET (1:30 p.m. PT) that afternoon (Press release, BioLife Solutions, MAY 11, 2020, View Source [SID1234557533]). Management will provide an overview of the Company’s financial results and a general business update.

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To access the webcast, log onto the Investor Relations page of the BioLife Solutions website at View Sourceearnings." target="_blank" title="View Sourceearnings." rel="nofollow">View Source Alternatively, you may access the live conference call by dialing (844) 825-0512 (U.S. & Canada) or (315) 625-6880 (International) with the following Conference ID: 2085346. A webcast replay will be available approximately two hours after the call and will be archived on View Source for 90 days.

On May 11, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported operating results for the first quarter ended March 31, 2020 (Press release, Sesen Bio, MAY 11, 2020, View Source [SID1234557452]). The Company also provided an update on the progress of manufacturing activities related to demonstrating analytical comparability between clinical batches of Vicinium and validation batches of Vicinium intended for potential future commercial use. The Company’s lead program, Vicinium, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the Company initiated the BLA submission for Vicinium to the FDA under Rolling Review.

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"In the first quarter of 2020, we successfully completed manufacturing of the pre-PPQ batch at Fujifilm," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We believe the commercial-scale cGMP batches of Vicinium manufactured to date at our CMOs are comparable to Vicinium previously manufactured by Sesen for use in our clinical trials. This reinforces our confidence in the upcoming PPQ campaign and our ability to demonstrate analytical comparability between clinical and commercial drug supply. The Company’s focus for 2020 remains the flawless execution of the PPQ campaign and the finalization of Module 3 to complete the Vicinium BLA submission."

Manufacturing Update

In February 2020, manufacturing of the pre-PPQ bulk drug substance batch was completed at Fujifilm. In April, quality release testing of the bulk drug substance from this batch was completed and all quality acceptance criteria were met. The Company believes these data de-risk the PPQ campaign and increase the likelihood of demonstrating analytical comparability. In addition, in April 2020, this batch from Fujifilm was used to manufacture the first PPQ drug product batch at Baxter and release testing is currently underway. The Company remains on track to complete the Vicinium BLA submission in the second half of 2020 and anticipates potential approval in first half of 2021. At this time, the Company does not expect any impact to the manufacturing activities or regulatory processes related to Vicinium due to COVID-19.
CHMP Scientific Advice Update

On May 7, 2020 the Company received clinical Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) stating that the Committee agreed that the Company’s nonclinical, clinical pharmacology and safety database are all sufficient to support a marketing authorization application (MAA). Furthermore, additional clinical trials were not requested by the CHMP in support of the MAA submission for Vicinium. Based on the guidance received, the Company expects to submit the MAA for Vicinium to the EMA in early 2021, with potential approval anticipated in early 2022.
Commercial Opportunity

In the first quarter of 2020, the Company conducted 30-minute interviews with 34 randomly selected, high-prescribing Urologists to assess their views of a blinded clinical profile of Vicinium as well as an unblinded profile of Keytruda, which was recently approved by the FDA for BCG-unresponsive NMIBC patients with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. The research revealed that, when prescribing a branded agent, Urologists would prescribe Vicinium to 83% of their patients compared to 17% for Keytruda. The overall preference for Vicinium was driven by comparable efficacy data to Keytruda with a favorable safety profile and mode of administration that would allow physicians to easily integrate Vicinium into their practices. We believe these data support the potential for a successful launch characterized by rapid uptake and growth of Vicinium.
First Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents were $42.5 million as of March 31, 2020, compared to $48.1 million as of December 31, 2019.
R&D Expenses: Research and development expenses for the first quarter of 2020 were $8.9 million compared to $4.7 million for the same period in 2019. The first quarter increase was due primarily to costs related to the ongoing technology transfer process as we scale-up for commercial manufacturing, in addition to increased regulatory costs partially offset by lower employee compensation and lower clinical expenses related to the Phase 3 VISTA trial for Vicinium.
G&A Expenses: General and administrative expenses for the first quarter of 2020 were $3.4 million compared to $3.1 million for the same period in 2019. The first quarter increase was due primarily to increases in professional fees and employee compensation, offset by reduced market research costs.
Net Income (Loss): Net income was $41.6 million, or $0.31 per basic share and $0.31 per diluted share, for the three months ended March 31, 2020, compared to a net loss of $6.5 million, or $0.08 per basic and diluted share, for the same period in 2019. The change was primarily the result of the non-cash change in fair value of contingent consideration due to significantly higher discount rates associated with current market conditions related to the COVID-19 pandemic.
Conference Call and Webcast Information

Members of the Sesen Bio management team will host a conference call and webcast today at 8:00 AM ET to review the Company’s financial results and provide a general business update. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 3780957. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.

About the VISTA Clinical Trial

The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium as a monotherapy in patients with high-risk, bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). The primary endpoints of the trial are the complete response rate and the duration of response in patients with carcinoma in situ with or without papillary disease. Patients in the trial received locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. To learn more about the Phase 3 VISTA trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.

About Vicinium

Vicinium, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On May 11, 2020 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the three months ended March 31, 2020, and provided a corporate update, including the Company’s actions to continue to support public health efforts and the health and safety of employees, patients and healthcare providers during the COVID-19 pandemic (Press release, Portola Pharmaceuticals, MAY 11, 2020, View Source [SID1234557490]).

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"2020 started strong with January representing our highest month of Andexxa demand in the U.S. since launch, driven in part by a return of growth in our tier one accounts," said Scott Garland, Portola’s president and chief executive officer. "While encouraging, the emergence of the COVID-19 pandemic impacted our revenue in March and the quarter due to three main factors. First, market research and customer feedback indicate that shelter-in-place restrictions issued by over 40 states have led to fewer patients coming into emergency departments. Second, most healthcare systems shifted their focus to preparing for and addressing COVID-19 patients, which impacted the number of new accounts added in the quarter. Finally, on March 13, we suspended face-to-face field interactions with healthcare providers. Despite these challenges, we continue to execute on our growth drivers and make progress with virtual meetings and education programs to highlight the value proposition of Andexxa, including recently presented clinical data."

As previously announced on May 5, 2020, Portola entered into a definitive merger agreement to be acquired by Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN). Under the terms of the merger agreement, a subsidiary of Alexion will commence a tender offer to acquire all of the outstanding shares of Portola common stock at a price of $18 per share in cash. The tender offer is subject to customary conditions, including the tender of a majority of the outstanding shares of Portola common stock, the expiration or termination of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976 and receipt of certain other regulatory approvals. Following successful completion of the tender offer, Alexion will acquire all remaining shares not tendered in the offer at the same price of $18 per share in cash through a merger. The transaction is expected to close in the third quarter of 2020.

Quarter Ending March 31, 2020, and Related Financial Results

•Total global revenues for the first quarter of 2020 were $26.4 million compared with $22.2 million for the same period in 2019. This includes $25.6 million in net product revenues from sales of Andexxa/Ondexxya [coagulation factor Xa (recombinant), inactivated-zhzo], and $0.8 million in collaboration and license revenues.

•Net loss attributable to Portola for the first quarter of 2020 was $68.8 million, or $0.88 net loss per share, compared with $78.2 million, or $1.17 net loss per share, for the same period in 2019.

•Total operating expenses for the first quarter of 2020 were $84.8 million, including $9.5 million in stock-based compensation, compared with $95.8 million for the same period in 2019. Included in total operating expenses was a stock-based compensation expense of $9.5 million for the first quarter of 2020, compared with $17.9 million, including one-time equity valuation for a manufacturer of $5.8 million, for the same period in 2019.

•Research and development (R&D) expenses for the first quarter of 2020 were $26.1 million compared with $35.6 million for the same period in 2019. Included in R&D expenses was a stock-based compensation expense of $2.6 million for the first quarter of 2020, compared with $10.1 million, including one-time equity valuation for a manufacturer of $5.8 million, for the same period in 2019.

•Selling, general and administrative (SG&A) expenses for the first quarter of 2020 were $54.4 million compared with $53.0 million for the same period in 2019. Included in SG&A expenses was a stock-based compensation expense of $6.9 million for the first quarter of 2020, compared with $7.8 million for the same period in 2019.

•Cost of sales (COS) for the first quarter of 2020 was $4.3 million compared with $7.2 million for the same period in 2019.

Cash, Cash Equivalents and Investments

Cash, cash equivalents and investments at March 31, 2020, totaled $394.1 million compared with $466.2 million as of December 31, 2019.

Updated 2020 Annual Financial Guidance

Portola is reducing its 2020 operating expenses by approximately $50 million. For the fiscal year 2020, Portola is updating its guidance for R&D and SG&A expenses. Portola now expects GAAP R&D expenses to be between $90 million and $105 million, including stock-based compensation expenses of approximately $15 million, a decrease of $15 million from the prior guidance range of $105 million and $120 million. Portola now expects GAAP SG&A expenses to be between $200 million and $215 million, including stock-based compensation expenses of approximately $38 million, a decrease of $35 million from the prior guidance range of $235 million and $250 million. This updated guidance reflects near-term cost containment measures to extend the cash runway as Portola navigates the COVID-19 pandemic.

With the uncertainty around the duration of COVID-19 impacts, Portola is suspending prior guidance provided during its fourth quarter 2019 call for approximately 350 new hospital adds in 2020.

COVID-19 Response

As the global pandemic continues to evolve rapidly, Portola’s first priority is the health and safety of employees, patients and healthcare providers. Effective March 13, 2020, the Company suspended face-to-face field activity and instituted a mandatory work-from-home policy for all employees, including those in the Company’s South San Francisco and European headquarters. The Company shifted to a virtual field force to continue engaging customers with digital tools and remote meetings where possible. Portola’s plan to present and publish data throughout the year remains intact.

At this time, the global Andexxa supply chain and distribution structure is intact for customers to continue to use and re-order Andexxa. Portola has adequate supply of this important medicine on hand for the next couple of years in the United States and Europe.

Recent Achievements and Events

·Added 68 new accounts in the first quarter of 2020. Andexxa is now stocked in over 700 U.S. hospitals.

·Establishment of a permanent J-code for Andexxa by the Centers for Medicare & Medicaid Services, effective July 1, 2020, ensuring greater patient access by providing hospitals with a clearer reimbursement pathway when administering Andexxa in the outpatient hospital setting.

·Presented the budget impact model demonstrating that using Andexxa may provide a net cost reduction for the treatment of intracranial hemorrhage (ICH) associated with oral Factor Xa inhibitors. The analysis, presented at the Emergencies on Medicine conference, projects that hospital use of Andexxa with NTAP reimbursement can reduce cost per hospitalization by up to $5,400 compared to 4F-PCC’s.

·Presented new data at ACC demonstrating that Andexxa was associated with a lower rate of in-hospital and 30-day mortality in patients with multiple types of life-threatening Factor Xa inhibitor-related bleeds compared with other treatment options. Propensity matched data from the ANNEXA-4 and ORANGE studies showed 30-day mortality was 15% with Andexxa versus 34% with 4F-PCC across all bleed types. Additionally, in a real-world database analysis, in-hospital mortality was 4% with Andexxa and 10% with 4F-PCC across all bleed types.

·Agreed to terminate the collaboration and license agreement with Bristol-Myers Squibb Company and Pfizer, Inc. regarding the development and commercialization of andexanet alfa in Japan. Portola will regain full Japanese rights for andexanet alfa. Japan represents the third largest market for Factor Xa inhibitors after the United States and the EU 5 countries. Portola will have exclusive rights to develop and commercialize andexanet alfa in the United States, Europe, Japan and rest of the world markets.

Planned Upcoming Milestones

·Present and publish comparative clinical, mechanistic and economic data supporting the adoption of Andexxa at medical meetings and in peer-reviewed journals throughout the year including:

oThe ANNEXA-4 study ICH subgroup

oRetrospective comparisons of Andexxa vs. 4F-PCC’s on clinical outcomes using data from the ANNEXA-4, ORANGE and RETRACE studies

·Advance reimbursement discussions in the United Kingdom (2H 2020), Germany (2H 2020) and other Wave 1 European countries.

·Submit a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) by year end for inclusion of the additional Factor Xa inhibitors edoxaban and enoxaparin in the Andexxa label.