On February 21, 2019 MPM Capital, a life-sciences venture capital firm investing in early-stage therapeutics companies, reported the closing of its seventh venture fund, BioVentures 2018 (BV2018) (Press release, MPM Capital, FEB 21, 2019, View Source [SID1234533553]). MPM is currently investing out of BV2018 and its two oncology-only funds with a total of over $1 billion in capital.

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With BV2018, MPM will continue to create and invest in innovative companies developing breakthrough therapies to treat severe unmet medical needs. The fund will focus on disruptive scientific developments across multiple therapeutic areas including oncology, immunology and neuroscience as well as emerging modalities of cell, gene and nucleic acid therapies.

"We’re grateful for our investors’ support of BV2018, which will allow us to continue to pursue our proven company-building strategy with the goal of improving healthcare outcomes while creating value for our investors," said Ansbert Gadicke, M.D., co-founder and Managing Director of MPM. "The opportunity to drive innovation in drug development is more attainable than ever before. We believe this is particularly true in oncology where MPM has 29 oncology portfolio investments and approximately $1 billion of capital dedicated to developing novel cancer therapies."

At the core of MPM’s company-building strategy is a team of fifteen Executive Partners working in close collaboration with the investment team to jointly harness scientific creativity, entrepreneurship, and financial and business insights. The Executive Partner team includes senior biopharma leaders with decades of experience in drug discovery, clinical development and commercialization. MPM’s team is involved in all aspects of company building, from identifying and evaluating new opportunities to creating companies and assuming senior leadership roles across the portfolio. Recent examples of companies founded and led by MPM Executive Partners include Harpoon Therapeutics and TCR2 Therapeutics, both of which recently completed IPOs, and Mitobridge and Potenza Therapeutics, both of which were recently acquired.

Since its first fund in 1997, MPM has raised $3.9 billion of capital. MPM’s BioVentures portfolio has collectively boasted 49 FDA-approved drugs and realized over 100 IPOs and acquisitions. With BV2018, MPM will continue to capitalize on favorable industry trends and the unprecedented rate of biomedical discovery and, importantly, leverage its well-established academic and industry relationships.

"Over two decades of investing, MPM has developed long-standing and strategic partnerships with academia, biotech and large pharma," said Luke Evnin, Ph.D., co-founder and Managing Director of MPM. "Vital to our objective of delivering new treatments to improve the lives of patients, these relationships support our ongoing discovery of next-generation translational science and provide financing and acquisition opportunities across our portfolio."

On February 21, 2019 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for 2018 (Press release, Cytokinetics, FEB 21, 2019, View Source [SID1234533580]). Net loss for 2018 was $106 million, or $1.95 per share, compared to net loss for 2017 of $128 million, or $2.59 per share. Cash, cash equivalents and investments totaled $199 million at December 31, 2018.

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"We had a productive fourth quarter 2018 highlighted by the expansion of our clinical pipeline of muscle-directed investigational medicines and the advancement of our wholly-owned cardiac myosin inhibitor which we are developing for the potential treatment of patients with hypertrophic cardiomyopathies," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Our progress is continuing with the achievement of key milestones under our partnered programs. Under our collaboration with Amgen, we recently opened METEORIC-HF to enrollment and expect GALACTIC-HF to complete enrollment in the next few months. In that same timeframe, we are also looking forward to results from FORTITUDE-ALS under our collaboration with Astellas. We believe that our pioneering leadership in muscle biology, alongside our partnerships and current financials, position us well for upcoming company milestones."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Continued enrollment in GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. Enrollment is nearing 90 percent completion with over 7,000 patients randomized to date having the high-risk profile intended by the trial design. GALACTIC-HF is being conducted by Amgen in collaboration with Cytokinetics.

Opened METEORIC-HF, (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. METEORIC-HF is a randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. METEORIC-HF is being conducted by Cytokinetics in collaboration with Amgen.
AMG 594 (cardiac troponin activator)

Began dosing in the Phase 1 study of AMG 594 to assess its safety, tolerability, pharmacokinetics and potential to increase cardiac function in healthy volunteers. AMG 594 is a novel, selective, oral, small molecule cardiac troponin activator, discovered under a joint research program with Amgen. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Continued enrollment in a Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-274 in healthy adult subjects. CK-274 is a wholly-owned, novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM).
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Received feedback from the U.S. Food and Drug Administration that the Six Minute Walk Test is an acceptable primary endpoint for a potential registration program for reldesemtiv in ambulatory patients with SMA.

Completed patient enrollment in FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial designed to assess the change from baseline in the percent predicted slow vital capacity and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv in patients with ALS. This Phase 2 trial is being conducted by Cytokinetics in collaboration with Astellas.

Announced data from FORTITUDE-ALS at the 29th International Symposium on ALS/MND in Glasgow, Scotland, UK, including patient baseline characteristics and demographics. Baseline characteristics of patients enrolled in FORTITUDE-ALS are similar to those of other recent large clinical trials in ALS, including BENEFIT-ALS and VITALITY-ALS.
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation FSTA, under our collaboration with Astellas.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; The companies are continuing their joint research program with Astellas providing sponsorship of Cytokinetics’ activities through 2019.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

Convened an R&D Day to provide an update on our expanded pipeline of muscle-directed drug candidates.
Financials

Revenues for 2018 included $29.4 million in revenue from our collaboration with Astellas and $1.9 million from our collaboration with Amgen. Revenues from Astellas in 2018 included $22.3 million for reimbursement of research and development expenses, $5.1 million in license revenue and $2.0 million in a milestone payment. Revenues from Amgen in 2018 include $1.9 million for reimbursement of research and development expenses. Revenues for 2017 were offset by $20.0 million for payments to Amgen related to our option to co-fund the Phase 3 development program of omecamtiv mecarbil in exchange for an increased royalty upon potential commercialization.

Research and development expenses decreased to $89.1 million in 2018 from $90.3 million in 2017, primarily due to the suspension of development of tirasemtiv in late 2017, offset in part by increased development activities for reldesemtiv and CK-274.

General and administrative expenses decreased to $31.3 million in 2018 from $36.5 million in 2017, primarily due to decreased commercial readiness activities.

2019 Financial Guidance

The company also announced financial guidance for 2019. The company anticipates cash revenue will be in the range of $28 to $32 million, operating expenses will be in the range of $110 to $115 million, and net cash utilization will be approximately $85 to $90 million.

2019 Corporate Milestones

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Expect to complete patient enrollment in GALACTIC-HF in the first half of 2019.

Expect the Data Monitoring Committee to conduct a first interim analysis for GALACTIC-HF, the design of which is tied to the potential for futility, in the first half of 2019.

Expect to continue patient enrollment in METEORIC-HF through 2019.
AMG 594 (cardiac troponin activator)

Expect the continued conduct of the Phase 1 study of AMG 594 through 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Expect data from a Phase 1 study of CK-274 in the second half of 2019.
Skeletal Muscle Program

reldesemtiv (next-generation FSTA)

Expect results from FORTITUDE-ALS in Q2 2019.
Pre-Clinical Research

Expect to continue joint research program with Astellas through 2019.

Expect to continue independent research activities directed to our other muscle biology research programs through 2019.
Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s fourth quarter 2018 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 9798766.

An archived replay of the webcast will be available via Cytokinetics’ website until February 28, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9798766 from February 21, 2019 at 7:30 PM Eastern Time until February 28, 2019.

On February 21, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the quarter and year ended December 31, 2018 (Press release, Emergent BioSolutions, FEB 21, 2019, View Source [SID1234533538]).

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2018 FINANCIAL PERFORMANCE

(I) Quarter Ended December 31, 2018 (Unaudited)

Revenues

Total Revenues
For Q4 2018, total revenues were $270.7 million, an increase of 40% over 2017. Total revenues reflect a significant increase in product sales due to the contribution of recently acquired products.

Product Sales
For Q4 2018, product sales were $217.4 million, an increase of $55.7 million or 34% as compared to 2017. The increase primarily reflects sales of NARCAN (naloxone HCl) Nasal Spray, Vivotif (Typhoid Vaccine Live Oral Ty21a) and Vaxchora (Cholera Vaccine, Live, Oral), all acquired in October 2018.

Contract Manufacturing
For Q4 2018, revenue from the Company’s contract manufacturing operations was $26.9 million, an increase of $10.7 million or 66% as compared to 2017. The increase primarily reflects increased manufacturing services for existing commercial customers at the Company’s Camden site.

Contracts and Grants
For Q4 2018, revenue from the Company’s development-based contracts and grants was $26.4 million, an increase of $10.5 million or 66% as compared to 2017. The increase primarily reflects increased R&D activities related to certain ongoing funded development programs, most notably NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant).

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For Q4 2018, cost of product sales and contract manufacturing was $113.2 million, an increase of $46.7 million or 70% as compared to 2017. The increase primarily reflects the impact of an increase in sales of NARCAN (naloxone HCl) Nasal Spray, which was acquired in the fourth quarter of 2018, and raxibacumab, which was acquired in the fourth quarter of 2017.

Research and Development (Gross and Net)
For Q4 2018, gross R&D expenses were $52.0 million, an increase of $23.5 million or 82% as compared to 2017. The increase primarily reflects an increase in costs associated with contract development services associated with NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant).

For Q4 2018, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was $25.6 million, an increase of $13.0 million or 103% as compared to 2017. The increase primarily reflects investment in process improvements related to ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) at the Canton site and increased costs associated with the Phase 2 clinical trial for the FLU-IGIV program. The Q4 2018 net R&D expense was 10% of net revenue (total revenue less contracts & grants) compared to 7% of net revenue in Q4 2017.

Selling, General and Administrative
For Q4 2018, selling, general and administrative expenses were $81.0 million, an increase of $39.2 million or 94% as compared to 2017. The increase primarily reflects higher transaction and integration related costs associated with the PaxVax and Adapt Pharma acquisitions.

Amortization of Intangible Assets
The Company has elected to reclassify amortization of intangible assets for Q4 2018 from cost of product sales and contract manufacturing to amortization of intangible assets, and therefore the Q4 2017 amounts have also been reclassified to conform to the current period presentation on the Company’s consolidated statements of operations.

For Q4 2018, amortization of intangible assets was $13.3 million versus $3.9 million as compared to 2017. The increase entirely reflects higher non-cash intangible asset amortization costs associated with the PaxVax and Adapt Pharma acquisitions, which both closed in the fourth quarter of 2018.

Income Taxes
For Q4 2018, the provision for income tax expense in the amount of $7.0 million includes the impact of non-deductible acquisition transaction costs and other permanent items. The effective tax rate for Q4 2018 is not meaningful given the low level of pre-tax income for the quarter.

Net Income (Loss) & Adjusted Net Income
For Q4 2018, the Company recorded a net loss of $3.4 million, or $0.07 per diluted share, versus net income of $33.9 million, or $0.67 per diluted share, in 2017. (2)

For Q4 2018, the Company recorded adjusted net income of $38.3 million, or $0.75 per diluted share, versus adjusted net income of $37.8 million, or $0.74 per diluted share, in 2017. (1) (2)

EBITDA & Adjusted EBITDA
For Q4 2018, the Company recorded EBITDA of $36.1 million versus $65.2 million in 2017. (1)

For Q4 2018, the Company recorded adjusted EBITDA of $75.0 million versus $67.1 million in 2017. (1)

(II) Year Ended December 31, 2018 (Unaudited)

Revenues

Total Revenues
For full year 2018, total revenues were $782.4 million, an increase of $221.5 million or 39% over 2017. Total revenues reflect significant increases in both product sales due to the contribution of recently acquired products and contract development and manufacturing services revenue.

Product Sales
For full year 2018, product sales were $606.5 million, an increase of $185.0 million or 44% as compared to 2017. The increase primarily reflects a full year of sales of ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) and raxibacumab, both acquired in the fourth quarter of 2017, and NARCAN (naloxone HCl) Nasal Spray, which was acquired in the fourth quarter of 2018.

Contract Manufacturing
For full year 2018, revenue from the Company’s contract manufacturing operations was $98.9 million, an increase of $30.0 million or 44% as compared to 2017. The increase primarily reflects the completion of a milestone related to the expansion of certain contract manufacturing capabilities at the Company’s Lansing site, fill/finish services provided to third parties, and increased manufacturing services for commercial customers at the Company’s Canton site.

Contracts and Grants
For full year 2018, revenue from the Company’s development-based contracts and grants was $77.0 million, an increase of $6.5 million or 9% as compared to 2017. The increase primarily reflects an increase in R&D activities related to SIAN, the Company’s drug-device combination product candidate (antidote spray device) for the treatment of known or suspected acute cyanide poisoning as well as work related to ACAM2000, (Smallpox (Vaccinia) Vaccine, Live), which was acquired in the fourth quarter of 2017.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For full year 2018, cost of product sales and contract manufacturing was $322.3 million, an increase of $134.6 million or 72% as compared to 2017. The increase primarily reflects the impact of an increase in Other product sales associated principally with a full year of sales of both ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) and raxibacumab, which were acquired in the fourth quarter of 2017, and NARCAN (naloxone HCl) Nasal Spray, which was acquired in the fourth quarter of 2018.

Research and Development (Gross and Net)
For full year 2018, gross R&D expenses were $142.8 million, an increase of $45.4 million or 47% as compared to 2017. The increase primarily reflects an increase in costs associated with development programs related to the Company’s recently acquired product candidates.

For full year 2018, net R&D expense was $65.8 million, an increase of $38.9 million or 145% as compared to 2017. The increase primarily reflects investment in manufacturing development activities related to ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) and the FLU-IGIV program. The full year 2018 net R&D expense was 9% of net revenue (total revenue less contracts & grants) compared to 5% of net revenue in 2017.

Selling, General and Administrative
For full year 2018, selling, general and administrative expenses were $202.5 million, an increase of $59.6 million or 42% as compared to 2017. The increase primarily reflects an increase in acquisition-related costs (transaction and integration) associated with the PaxVax and Adapt acquisitions, compensation related costs from increased headcount and share-based compensation expense, and infrastructure improvement initiatives primarily related to IT systems.

Amortization of Intangible Assets
The Company has elected to reclassify amortization of intangible assets for full year 2018 from cost of product sales and contract manufacturing to amortization of intangible assets, and therefore the 2017 amounts have been reclassified to conform to the current period presentation on the Company’s consolidated statements of operations.

For full year 2018, amortization of intangible assets was $25.0 million versus $8.6 million as compared to 2017. The increase entirely reflects higher non-cash intangible asset amortization costs associated with the PaxVax and Adapt Pharma acquisitions, which both closed in the fourth quarter of 2018.

Income Taxes
For full year 2018, the provision for income tax expense in the amount of $18.8 million includes the impact of state taxes, GILTI (Global Intangible Low Income Tax), acquisition transaction costs and other non-deductible items. These are partially offset by the benefit relating to finalizing the impact of Tax Reform and the stock option deduction, resulting in an effective tax rate of 23%.

Net Income & Adjusted Net Income
For full year 2018, the Company recorded net income of $62.7 million, or $1.22 per diluted share, versus net income of $82.6 million, or $1.71 per diluted share, in 2017. (2)

For full year 2018, the Company recorded adjusted net income of $119.6 million, or $2.33 per diluted share, versus adjusted net income of $95.7 million, or $1.90 per diluted share, in 2017. (1) (2)

EBITDA & Adjusted EBITDA
For full year 2018, the Company recorded EBITDA of $152.7 million versus $166.0 million in 2017. (1)

For full year 2018, the Company recorded adjusted EBITDA of $198.8 million versus $175.7 million in 2017. (1)

The company’s financial forecast for 2019 includes the impact of the following items:

continued deliveries of BioThrax to the Strategic National Stockpile (SNS) under the current procurement contract with the Centers for Disease Control and Prevention (CDC), (the contract and the SNS are now managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR));

initial deliveries of NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant) to the SNS following expected Emergency Use Authorization pre-approval by the U.S. Food and Drug Administration (FDA) under the company’s current development and procurement contract with the Biomedical Advanced Research and Development Authority (BARDA);

full year sales of NARCAN Nasal Spray, Vaxchora (Cholera Vaccine, Live, Oral), and Vivotif (Typhoid Vaccine Live Oral Ty21a), all of which were acquired in the fourth quarter of 2018;

completion of deliveries of ACAM2000 to the SNS under the prior contract as well as initiation of new deliveries to the SNS under the anticipated follow-on procurement contract with the ASPR;

deliveries of raxibacumab to the SNS under the current procurement contract with BARDA;

domestic and international sales of the other medical countermeasures that comprise Other Product sales;

continued CDMO services revenue;

increased Contract & Grant revenue due to anticipated increased work related to development projects funded by third parties; and

continued investment in discretionary development projects funded by the company targeting opportunities in medical countermeasures for existing and emerging infectious diseases, opioid overdose and other public health threats.

The outlook for 2019 does not include estimates for potential new corporate development or other M&A transactions.

Q1 2019 REVENUE FORECAST (Reaffirmed)
For Q1 2019, the company reaffirms its expectation of total revenues of $185 to $205 million.

FOOTNOTES

See "Reconciliation of Net Income (Loss) to Adjusted Net Income, EBITDA and Adjusted EBITDA" for a definition of terms and a reconciliation table.

See "Calculation of Diluted Earnings Per Share."

CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 5:00 pm (Eastern Time) today, February 21, 2019, to discuss these financial results. This conference call can be accessed live by telephone or through Emergent’s website:

Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 2299983

Live Webcast Information:
Visit View Source for the live webcast feed.

On February 21, 2019 Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, reported that Scott Myers, Chairman and Chief Executive Officer, will present at the 8th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 27, 2019 at 1:30 p.m. ET (10:30 a.m. PT) at the Lotte New York Palace in New York City (Press release, Rainier Therapeutics, FEB 21, 2019, View Source [SID1234533554]).

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On February 21, 2019 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported today that the Company will release its fourth quarter and full year 2018 financial results after the market closes on Thursday, February 28, 2019 (Press release, Sangamo Therapeutics, FEB 21, 2019, View Source [SID1234533581]). The press release will be followed by a conference call at 5:00 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a business update.

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The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 6875578. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 6875578.