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Portola Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Corporate Update

On November 7, 2018 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the three months ended September 30, 2018 and provided a corporate update (Press release, Portola Pharmaceuticals, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2376001 [SID1234530994]).

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"I am excited to join Portola at such a pivotal moment in the Company’s history. Having just completed my first month in role, I am very encouraged by the progress and momentum we’ve achieved since prioritizing Andexxa, including our preparations for the potential approval of Generation 2 supply in the United States and in Europe," said Scott Garland, Portola’s president and chief executive officer. "The early feedback from our first full quarter of sales gives us confidence in the significant long-term potential for Andexxa, and we are now implementing our new focused strategy for Bevyxxa. I am also excited about the potential for cerdulatinib, which recently received Orphan Drug Designation. We have a number of critical milestones ahead that I expect we will achieve and we look forward to delivering our life-saving medications to more patients, and driving sustainable growth and value for shareholders."

Third Quarter 2018 Financial Results
Total revenue for the third quarter of 2018 was $14.2 million, compared with $3.8 million for the third quarter of 2017. This includes $7.7 million in product revenue for our first full quarter of Andexxa sales and $7.0 million in collaboration and license revenues. Bevyxxa product orders remained relatively flat in the third quarter, during which we recognized a net product loss for Bevyxxa of $552 thousand. This adjustment was primarily related to potential returns of initial launch quantities provided to wholesalers.

Total operating expenses for the third quarter of 2018 were $83.3 million, compared with $84.3 million for the same period in 2017. Total operating expenses for the third quarter of 2018 included $11.4 million in stock-based compensation expense, compared with $10.1 million for the same period in 2017.

Research and development expenses were $40.2 million for the third quarter of 2018, compared with $55.3 million for the third quarter of 2017. The decrease is driven primarily by the timing of manufacturing costs for Andexxa Generation 2 campaigns. Approximately $12 million, or 30 percent, of R&D expense for the quarter and $75 million, or 45 percent, for nine months year-to-date of total R&D expense was related to Andexxa manufacturing.

Selling, general and administrative expenses for the third quarter of 2018 were $38.8 million, compared with $28.9 million for the same period in 2017, reflecting the investment in our field force and marketing for our product launches.

For the third quarter of 2018, Portola reported a net loss of $71.3 million, or $1.08 net loss per share, compared with a net loss of $82.9 million, or $1.41 net loss per share, for the same period in 2017.

Cash, cash equivalents and investments at September 30, 2018 totaled $380.9 million, compared with $534.2 million as of December 31, 2017.

2018 Annual Financial Guidance
For the fiscal year 2018, Portola is updating its guidance for GAAP operating expenses, which are now expected to be between $355 million and $365 million, a decrease from the prior guidance range of between $390 million and $430 million, both including stock-based compensation. The updated guidance reflects the Company’s narrowed focus on a group of key hospitals for the Bevyxxa launch, as well as additional cost savings for the year.

Recent Achievements and Events

Appointed industry veteran Scott Garland as president and chief executive officer.
Submitted Prior Approval Supplement (PAS) to U.S. FDA for large-scale Generation 2 Andexxa manufacturing process; assigned a PDUFA date of December 31, 2018.
Transitioned commercial focus to the ongoing Andexxa U.S. launch under the Early Supply Program.
Secured New Technology Add-on Payment (NTAP) for Andexxa, which became effective as of October 1, 2018.
Implemented new strategy for Bevyxxa U.S. launch focused on establishing 10 Centers of Excellence to provide a model for driving broader adoption.
Received Orphan Drug Designation from the U.S. FDA for cerdulatinib for the treatment of peripheral T-cell lymphoma.
Eight abstracts presented at the European Society of Cardiology (ESC) meeting.
Upcoming Milestones

Anticipated broad launch of Andexxa upon U.S. FDA approval of Generation 2 supply.
Committee for Medicinal Products for Human Use (CHMP) opinion on andexanet alfa, with potential for European approval of andexanet alfa in the first half of 2019.
End-of-Phase 2 meeting and determination of regulatory path forward for cerdulatinib in Q1 2019.
New interim Phase 2a study results for cerdulatinib to be presented in an oral session at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Also accepted for presentation: outcomes-based research on the burden of hospital readmissions for venous thromboembolism among patients with cancer (oral) and two poster presentations on andexanet alfa.
Conference Call Details
Portola will host a conference call today, Wednesday, November 7, 2018, at 4:30 p.m. ET, during which time management will discuss the third quarter 2018 financial results, updates on the U.S. launches of Andexxa and Bevyxxa, and other matters. The live call can be accessed by phone by dialing (844) 452-6828 from the U.S. and Canada or 1 (765) 507-2588 internationally and using the passcode 3387315. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

Immunomedics Announces First Quarter Fiscal 2019 Results and Provides Corporate Update

On November 7, 2018 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the first quarter ended September 30, 2018 (Press release, Immunomedics, NOV 7, 2018, View Source [SID1234530991]). The Company also highlighted recent key progress and planned activities for its sacituzumab govitecan program. Please refer to the Company’s Quarterly Report on Form 10-Q filed today with the SEC for more details on the Company’s financial results.

The Company has made significant progress in the first fiscal quarter with an ongoing focus on regulatory, clinical, manufacturing and launch preparatory efforts and will continue to work closely and collaboratively with the FDA to address outstanding review issues in connection with our Biologics License Application for sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC).

"Patients with mTNBC are in dire need of better treatment options," said Michael Pehl, President and Chief Executive Officer of Immunomedics. "Our entire team is dedicated to bringing sacituzumab govitecan, with its highly differentiated benefit/risk profile, to these patients and focused on a potential marketing approval by the PDUFA date of January 18, 2019. We are well underway with commercial launch preparations, including the official onboarding of the salesforce this week, while we continue to expand our manufacturing collaborations and clinical plans to reflect our long-term commitment to cover multiple underserved indications and expanded geographies in the future."

Highlights of Recent Progress

The Company has entered into a long-term manufacturing partnership with Samsung BioLogics Co., Ltd as our second source manufacturer of hRS7, the antibody used in sacituzumab govitecan, to further enhance our supply chain and prepare for future demand driven by additional indications and broadening of our geographic footprint.

The Company has recruited and is in the process of training fifty highly-qualified sales representatives, all of whom have experience in the breast cancer field. In addition, the commercial leadership team across marketing, sales, sales operations, and market access is now fully staffed.

The Company has broadened its ongoing clinical collaboration with AstraZeneca and its global biologics research and development arm, MedImmune, on the development of the combination of durvalumab and sacituzumab govitecan to include second-line metastatic non-small cell lung cancer (NSCLC), leveraging AstraZeneca’s existing development infrastructure.
First Quarter Fiscal 2019 Results
The Company had no revenues in the three-month period ended September 30, 2018 due primarily to the discontinued sale of LeukoScan during the third quarter of fiscal 2018 in order for the Company to focus on its ADC business. Revenues in the three-month period ended September 30, 2017 were approximately $0.7 million.

Total costs and expenses were $57.2 million for the three months ended September 30, 2018, compared to $22.3 million for the three months ended September 30, 2017, due primarily to a $20.9 million increase in research and development expenses, a $8.5 million increase in general and administrative expenses, and a $5.6 million increase in sales and marketing expenses. Most of these increases were attributable to activities related to preparations for the potential approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for metastatic TNBC in the United States.

The Company recognized $1.2 million in non-cash income for the three months ended September 30, 2018, compared to $86.4 million in non-cash expense for the three months ended September 30, 2017. The decrease in expense was due primarily to the exercise of warrants, partially offset by an increase in the fair market value of warrants outstanding. Interest expense was $10.1 million for the three months ended September 30, 2018, compared to $2.6 million for the three months ended September 30, 2017. The increase was due primarily to increased debt balances as a result of the agreement with RPI Finance Trust.

Net loss attributable to stockholders was $64.2 million, or $0.34 per share, for the three months ended September 30, 2018, compared to $118.7 million, or $0.97 per share, for the same quarter in fiscal 2018.

As of September 30, 2018, the Company had $585.5 million in cash, cash equivalents, and marketable securities, which it believes is sufficient to support its next phase of growth; further build its clinical, medical affairs, commercial, and manufacturing infrastructure; begin its effort to commercialize sacituzumab govitecan globally; and fund its operations into 2021.

Balance Sheet
On October 5, 2018, Immunomedics completed the exchange of approximately $12.9 million in aggregate principal amount of its 4.75% Convertible Senior Notes due 2020 (Convertible Senior Notes) for newly issued shares of the Company’s common stock, pursuant to privately negotiated exchange agreements entered into between the Company and a limited number of holders of the Convertible Senior Notes. The remaining aggregate principal amount of the Convertible Senior Notes is approximately $7.1 million.

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss financial results for the first quarter fiscal 2019 and review key clinical developments and planned activities. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 1568527. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

Momenta Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Corporate Update

On November 7, 2018 Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) reported its financial results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, Momenta Pharmaceuticals, NOV 7, 2018, View Source [SID1234530989]).

"We recently highlighted our pipeline of novel drug candidates for immune-mediated disorders at our recent R&D Day and, as we look to early 2019, we plan to have two Phase 2 trials of M281 initiated in gMG and HDFN and one Phase 1/2 trial of M254 initiated in ITP," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "To complement the advancement of our novel drug pipeline, we have ongoing revenues from our Glatopa franchise as well as two late-stage biosimilar assets which have the potential to be important revenue drivers to support our novel drug pipeline. We recently executed agreements with AbbVie enabling the global launch of M923, our proposed biosimilar to HUMIRA, in the European Union and in the United States in November 2023, subject to regulatory approval. Additionally, our research platform is showing broad applicability and we believe it will generate additional pipeline expansion opportunities."

Third Quarter 2018 Highlights and Recent Events

Complex Generics:

Glatopa Products: a fully substitutable, AP-rated generic version of three-times-a-week COPAXONE 40 mg/mL and daily COPAXONE 20 mg/mL (glatiramer acetate injection) for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz

· In the third quarter of 2018, Momenta recorded $13.6 million in product revenues from Sandoz’s sales of Glatopa 20 mg/mL and 40 mg/mL products.

Novel Drugs for Rare Autoimmune and Immune-mediated Diseases:

M281 (anti-FcRn): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)

· On October 11, 2018, Momenta presented additional data from its Phase 1 study of M281 in healthy volunteers. M281 exhibited dose-dependent pharmacodynamics, rapid onset of target receptor occupancy, a self-limited IgG decrease to a mean maximum percent reduction of approximately 84% of baseline, and loss of target occupancy and IgG recovery observed at consistent times after the last dose. Single doses up to 60 mg/kg or 15 or 30 mg/kg administered weekly for up to 4 weeks by intravenous infusion were well-tolerated with no serious adverse events, few moderate adverse events (AEs) and a low incidence of infection-related AEs similar to placebo treatment. The full data from the Phase 1 study has been accepted for publication. The Company expects the data to be published before the end of 2018.

· On October 11, 2018 Momenta announced that it plans to commence two Phase 2 proof of concept clinical trials, one in generalized myasthenia gravis (gMG) and one in hemolytic disease of the fetus and newborn (HDFN), in the fourth quarter of 2018.

M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL

· CSL’s Phase 1 study in healthy volunteers to evaluate the safety and tolerability of M230 is ongoing and is targeted to be completed in 2019.

M254 (hsIgG): a hyper-sialylated immunoglobulin designed to be a higher potency alternative to intravenous immunoglobulin (IVIg) with the potential for enhanced safety and convenience

· The Company is targeting the initiation of a Phase 1/2 proof of concept study in immune thrombocytopenic purpura (ITP) in early 2019, pending regulatory feedback.

Biosimilars:

On October 1, 2018, Momenta announced that as a result of its strategic review the Company plans to advance its two late-stage biosimilar assets, M923, its wholly-owned proposed biosimilar to HUMIRA, and M710, its proposed biosimilar to EYLEA being developed in collaboration with Mylan. Momenta has initiated discussions with its collaboration partner, Mylan, to exit its participation in the development of its five other biosimilar programs including M834, a proposed biosimilar to ORENCIA (abatacept).

M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)

· On November 6, 2018 Momenta announced it had entered into a settlement with AbbVie Inc., to enable the commercialization of M923. Under the terms of the agreements and subject to approval by health regulatory authorities, Momenta may launch M923 in the

United States on November 20, 2023 and in Europe upon approval by the European Medicines Agency.

· Momenta plans to submit a biologics license application for M923 with the U.S. Food and Drug Administration in the fourth quarter of 2018 and a marketing authorization application in the European Union in the first half of 2019.

· The Company is working to identify commercialization partners for M923.

M710: a proposed biosimilar to EYLEA (aflibercept) candidate being developed in collaboration with Mylan

018, Mylan initiated a pivotal clinical trial in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with EYLEA.

Third Quarter 2018 Financial Results

Revenue: In the third quarter of 2018, the Company recorded $13.6 million in product revenues from Sandoz’s sales of Glatopa 20 mg/mL and 40 mg/mL products compared to $10.9 million in profit share from Sandoz sales of Glatopa 20 mg/mL for the same period in 2017. The increase in product revenues of $2.7 million, or 25%, was primarily due to a non-recurring deduction of a $5.0 million contractual amount in 2017, offset by lower net sales of Glatopa driven by Mylan N.V.’s entry into the COPAXONE market.

Research and development revenue for the third quarter of 2018 was $1.3 million compared to $13.2 million recorded in the same quarter last year. The decrease in research and development revenue of $11.9 million, or 90%, was primarily due to a $10.0 million milestone achieved in the 2017 period and lower reimbursable expenses for the Company’s complex generic programs.

Total revenues for the third quarter of 2018 were $14.9 million compared to $24.1 million for the same period in 2017.

Operating Expenses: Total GAAP operating expenses, were $66.7 million in the third quarter of 2018. In the third quarter of 2018, Momenta recorded $15.5 million of restructuring charges included in total GAAP operating expenses in connection the Company’s restructuring announced on October 1, 2018.

Research and development expenses for the third quarter of 2018 were $30.7 million, compared to $37.9 million for the same period in 2017. The decrease of $7.2 million, or 19%, was primarily due to a decrease in external R&D expenses for M923 offset by increases in spending for M281 and M230.

General and administrative expenses for the third quarter of 2018 were $20.4 million, compared with $20.7 million for the same period in 2017. General and administrative expenses for the third quarter of 2018 includes professional fees of $1.0 million incurred in connection with the Company’s strategic review.

Third quarter non-GAAP operating expenses were $45.7 million. Non-GAAP operating expenses is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense, restructuring costs and collaborative reimbursement revenues. See "Non-GAAP Financial Information and Other Disclosures" and the table below entitled "Reconciliation of GAAP Results to Non-GAAP Financial Measures" for a reconciliation of GAAP operating expense to non-GAAP operating expense.

Net Loss: The Company reported a net loss of $50.3 million, or $0.65 per share for the third quarter of 2018 compared to a net loss of $33.2 million, or $0.44 per share for the same period in 2017. The net loss for the third quarter includes restructuring charges of $15.5 million.

Cash Position: At September 30, 2018, Momenta had $281.6 million in cash, cash equivalents and marketable securities compared to $321.2 million at June 30, 2018.

2018 Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP financial measures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.

Non-GAAP operating expense is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense, restructuring costs, and collaborative reimbursement revenues. Today, Momenta is providing updated non-GAAP operating expense guidance of approximately $230 – $240 million for 2018 and $45 – $55 million for the fourth quarter of 2018. Approximately $1.4 million in additional charges related to the restructuring are anticipated to be recorded in the quarter ending December 31, 2018. The Company expects to continue to recognize revenue from Mylan’s $45 million upfront payment on a quarterly basis. The Company also estimates that collaborative reimbursement revenues will be approximately $0 – $2 million in the fourth quarter of 2018.

Non-GAAP Financial Information and Other Disclosures

Momenta uses a non-GAAP financial measure, non-GAAP operating expense, to provide operating expense guidance. Momenta believes this non-GAAP financial measure is useful

to investors because it provides greater transparency regarding Momenta’s operating performance as it excludes non-cash stock compensation expense, restructuring costs and collaborative reimbursement revenues. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Momenta’s liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Momenta’s operating results as reported under GAAP. Momenta has not provided GAAP reconciliation for its forward-looking non-GAAP annual or quarterly operating expense because Momenta cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the forward-looking non-GAAP financial measure. The Company has provided the estimated reconciling information that is available without unreasonable effort in the section of this press release above entitled "2018 Financial Guidance."

Conference Call Information

Management will host a conference call and webcast today at 8:00 am ET to discuss these results and provide an update on the Company. A live webcast of the conference call may be accessed on the "Investors" section of the Company’s website, www.momentapharma.com. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

To access the call you may also dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 3079348. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through November 14, 2018. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 3079348

Bristol-Myers Squibb to Take Part in Credit Suisse 2018 Health Care Conference

On November 7, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will take part in the Credit Suisse Annual Health Care Conference on Wednesday, November 14, 2018 in Scottsdale, AZ. Chris Boerner, chief commercial officer, will answer questions about the company at 8 a.m. MT (10 a.m. ET (Press release, Bristol-Myers Squibb, NOV 7, 2018, View Source [SID1234530988])).

Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

Jazz Pharmaceuticals Announces Participation at Upcoming Investor Conferences

On November 7, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will be webcasting its corporate presentations at four upcoming investor conferences (Press release, Jazz Pharmaceuticals, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375980 [SID1234530973]).

Stifel Healthcare Conference in New York, NY on Wednesday, November 14, 2018 at 9:30 a.m. EST / 2:30 p.m. GMT. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.
Jefferies London Healthcare Conference in London on Wednesday, November 14, 2018 at 9:20 a.m. GMT / 4:20 a.m. EST. Iain McGill, senior vice president, Jazz Pharmaceuticals Europe and rest of world, will provide an overview of the company and a business and financial update.
Evercore ISI Healthcare Conference in Boston, MA on Tuesday, November 27, 2018 at 8:00 a.m. EST / 1:00 p.m. GMT. Matt Young, executive vice president and chief financial officer, will provide an overview of the company and a business and financial update.
Piper Jaffray 30th Annual Healthcare Conference in New York, NY on Wednesday, November 28, 2018 at 11:00 a.m. EST / 4:00 p.m. GMT. Matt Young, executive vice president and chief financial officer, will provide an overview of the company and a business and financial update.
A live audio webcast of each presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at View Source Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at View Source