On November 6, 2017 Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy services, reported financial results for the quarter ended September 30, 2017 (Press release, Diplomat Speciality Pharmacy, NOV 6, 2017, View Source [SID1234521604]). All comparisons, unless otherwise noted, are to the quarter ended September 30, 2016.

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Diplomat Specialty Pharmacy (PRNewsFoto/Diplomat Pharmacy, Inc.)

Third Quarter 2017 Highlights include:

Revenue of $1,125 million, compared to $1,181 million
Total prescriptions dispensed of 222,000, compared to 266,000
Gross margin of 7.6% versus 6.6%
Gross profit per prescription dispensed of $360, compared to $289
Net income attributable to Diplomat of $1.0 million, compared to $5.4 million
Adjusted EBITDA of $23.2 million, compared to $22.6 million
Adjusted EBITDA margin of 2.1% versus 1.9%
EPS of $0.01 per diluted common share versus $0.08
Adjusted EPS of $0.25 versus $0.21
Phil Hagerman, CEO and Chairman of Diplomat, commented “Diplomat’s third quarter results were solid as we achieved financial results in-line with our expectations, experienced continued growth in our oncology and infusion businesses and expansion in our access to limited distribution drugs, as well as encouraging trends within the specialty pharmacy industry. I am pleased to announce we have resolved our arbitration with CVS and have transitioned from a PSAO contract to a direct contract with CVS, one of the nation’s largest health care companies. 2017 is a transition year for Diplomat, and we continue to make significant strides, including broadening our services through our acquisitions of NPS and 8th Day Software and enhancing our senior management team to execute on our strategy to become a broader-based health care company.”

Third Quarter Financial Summary:

Revenue for the third quarter of 2017 was $1,125 million, compared to $1,181 million in the third quarter of 2016. The decrease was driven by a loss of approximately $118 million due to contracts that were not renewed in 2017 and approximately $89 million due to a decrease in the demand for hepatitis C drugs versus the prior year period. These decreases were partially offset by approximately $64 million from the impact of manufacturer price increases, approximately $47 million from increased volume and mix with existing payor contracts, approximately $25 million of revenue from our recent acquisitions, and approximately $15 million from drugs that were new in the past year. Our revenue increase year over year excluding the impact of the contract losses was approximately 6%.

Gross profit in the third quarter of 2017 was $85.3 million and generated a 7.6% gross margin, compared to $78.5 million and 6.6% in the third quarter of 2016. The gross margin increase in the quarter was primarily due to the continued growth of our specialty infusion therapeutic category, the impact of our WRB Communications acquisition, each having higher margins, the receipt and recognition of approximately $1 million of insurance proceeds, and the non-repeat of an approximately $4 million direct and indirect remuneration (“DIR”) fee true-up that occurred in the year ago period.

Selling, general, and administrative expenses (“SG&A”) for the third quarter of 2017 were $83.0 million, an increase of $5.9 million, compared to $77.1 million in the third quarter of 2016. Of this change, $4.9 million related to employee cost, of which $5.2 million was employee cost for our recently acquired entities partially offset by operational efficiencies. Also contributing to the SG&A increase was a $2.4 million increase in amortization expense from definite-lived intangible assets, and a $1.9 million increase in the fair value of contingent consideration, both of which are associated with our acquired entities. We also experienced increases in other SG&A; including professional fees, workers’ compensation insurance, and other miscellaneous expenses. These increases were partially offset by the non-repeat of a $4.8 million impairment expense to fully impair certain definite-lived intangible assets in the prior year period. As a percentage of revenue, SG&A excluding change in fair value of contingent consideration and the prior year period impairment was 7.2% for the three months ended September 30, 2017, compared to 6.1% in the prior year period. This increase is primarily attributable to acquisition related amortization, professional fees, and the increased operating complexity associated with both our acquisitions and new drugs.

Net income attributable to Diplomat for the third quarter of 2017 was $1.0 million compared to $5.4 million in the third quarter of 2016. This decrease was primarily driven by the revenue, gross profit, and SG&A explanations above, as well as a $2.6 million change in income taxes. Adjusted EBITDA for the third quarter of 2017 was $23.2 million compared to $22.6 million in the third quarter of 2016.

Earnings per share for the third quarter of 2017 was $0.01 per basic/diluted common share, compared to $0.08 per basic/diluted common share for the third quarter of 2016. Diluted non-GAAP adjusted earnings per share (“Adjusted EPS”) was $0.25 in the third quarter of this year compared to $0.21 in the third quarter of 2016.

2017 Financial Outlook

For the full-year 2017, we are updating our previous financial guidance:

Revenue between $4.4 and $4.6 billion, versus the previous range of $4.3 and $4.6 billion
Net income attributable to Diplomat between $10 and $14 million, versus the previous range of $10 and $16 million
Adjusted EBITDA between $99 and $102 million, versus the previous range of $97 and $103 million
Diluted EPS between $0.15 and $0.20, versus the previous range of $0.15 and $0.23
Adjusted EPS between $0.82 and $0.87, versus the previous range of $0.71 and $0.79
Our EPS and Adjusted EPS expectations assume approximately 68,600,000 weighted average common shares outstanding on a diluted basis and a tax rate of 19%, versus the previous tax rate of 26%, for the full year 2017, which could differ materially.

Earnings Conference Call Information

As previously announced, the Company will hold a conference call to discuss its third quarter performance this evening, November 6, 2017, at 5:00 p.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833-286-5805 (or 647-689-4450 for international callers) and referencing participant code 95696083 approximately 15 minutes prior to the call. A webcast and audio file of the conference call will be available on the investor relations section of the Company’s website for approximately 90 days at ir.diplomat.is.

On November 6, 2017 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP) (ADR: EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells (“ERYTECH” or the “Company”), reported a business update and its financial results for the quarter ended September 30, 2017

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Business Highlights

In September 2017, ERYTECH presented full results from its open-label, multi-center, randomized Phase 2b trial of eryaspase in combination with chemotherapy for the treatment of second-line metastatic pancreatic cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid. In October 2017, the Company met with the FDA to discuss further development of eryaspase for the pancreatic cancer indication and intends to meet with the EMA to also discuss the design of a Phase 3 clinical trial that the Company hopes to initiate during the third quarter of 2018. The Company expects that the Phase 3 clinical trial will be designed to study the safety and efficacy of eryaspase combined with chemotherapy in patients with second-line metastatic pancreatic cancer. The trial is expected to enroll approximately 400 to 600 patients across clinical sites in the United States and Europe. The Company expects the primary endpoint of the trial to measure overall survival, and the main secondary endpoints will include progression-free survival, objective response rate, disease control rate, quality of life and safety. ERYTECH is also considering proof-of-concept studies in first-line pancreatic cancer and other settings and has initiated further preclinical work to assess the combinability of eryaspase with other compounds used in the treatment of first-line pancreatic cancer patients.

In October 2017, the Company resubmitted its MAA for eryaspase (GRASPA) for the treatment of patients with R/R ALL to the EMA. The validation of the MAA by the EMA is ongoing, after which the EMA will begin its formal assessment.

In September 2017, the Company announced the determination of the recommended Phase 2 dose in its U.S. Phase 1 dose escalation trial of eryaspase (GRASPA) as a first-line treatment of adult ALL patients at the level of 100 U/kg. This dose had been previously recommended following ERYTECH’s Phase 2 trial in elderly ALL patients. It is also the dose level used in the Company’s Phase 2b trial in second-line, metastatic pancreatic cancer and in its ongoing Phase 2b trial in AML, from which top-line results are expected by the end of 2017.

Preclinical development activities of other product candidates are progressing:
In September, ERYTECH presented preclinical data on its eryminase and erymethionase programs at the 13th International Congress of Inborn Errors of Metabolism (ICIEM). Both programs underscore ERYTECH’s opportunities with companies active in the field of metabolic diseases and enzyme replacement therapies. Further proof of concept data are expected during the course of 2018.

ERYTECH continues to explore the use of its proprietary ERYCAPS platform to encapsulate tumor antigens within red blood cells as an innovative approach to cancer immunotherapy. The Company expects to complete preclinical proof-of-concept studies of ERYMMUNE during the course of 2018.
Financial Highlights

Net loss for the nine-month period ended September 30, 2017 was €20.8 million, compared to €16.1 million for the same period in the prior year. The €4.7 million increase reflected increased activity to advance the Company’s ongoing preclinical and clinical development programs and was primarily related to the clinical and regulatory progress of product development projects, and higher personnel costs incurred due to the previously announced staffing of key positions in the Company’s preclinical, clinical and pharmaceutical operations, to address the Company’s activity expansion and prepare the Company for the next stages of its development strategy.

As of September 30, 2017, ERYTECH had cash and cash equivalents totaling €80.3 million, compared with €88.6 million as of June 30, 2017 and €37.6 million as of December 31, 2016. Total net cash utilization was €8.3 million in the third quarter of 2017 and €22.8 million for the nine-month period ended September 30, 2017, excluding the €65.2 million net proceeds from the Company’s April 2017 capital raise.

The financial results for the three and nine months ended September 30, 2017 were in line with ERYTECH’s established strategy for 2017 and reflected the strengthening of the Company’s operations, which focuses on preparing the Company for its next stage of development, including its expected launch in 2018 of a Phase 3 clinical trial in second line metastatic pancreatic cancer in Europe and the United States. Management believes that its cash and cash equivalents available at September 30, 2017 are sufficient to fund our clinical trials that have already commenced, on the basis of its current cost structure and its ongoing programs, to ensure its viable going concern through the 2020 horizon.

Key newsflow and milestones expected over the next 12 months

Expect to report results from EU Phase 2b AML study in Europe
Meeting with CHMP on PDAC development plan
Meeting with FDA on ALL development plan
Potential initiation of Phase 3 trial in second-line PDAC in Europe and the U.S.
Potential initiation of clinical studies in first-line PDAC and other solid tumors
Potential launch of Phase 3 trial in first-line adult ALL
Potential launch of Phase 3 trial in AML
Expected initiation of erymethionase Phase 1 study

Next financial updates:

Financial highlights for the 4th quarter and full-year 2017: March 12, 2018 (after market close), followed by a conference call and webcast on March 13, 2018 (1:30pm CET/8:30am EDT)
Upcoming participations at investor conferences:

Jefferies Global Healthcare Conference, November 15-16, 2017, London
Actionaria, November 23-24, 2017, Paris
Geneva European Midcap Event, November 28-29, Geneva
Biomed Invest Securities, December 19, Paris
Investor access event at the J.P. Morgan Healthcare Conference, January 8-11, 2018, San Francisco
ODDO BHF Forum, January 11-12, 2018, Lyon

On November 6, 2017 Portola Pharmaceuticals Inc. (Nasdaq:PTLA) will report financial results and provide a corporate update for the quarter ended September 30, 2017 (Press release, Portola Pharmaceuticals, NOV 6, 2017, View Source [SID1234521609]).

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“Following FDA approval of our first product, Bevyxxa, our team has been working diligently to bring this important new medicine to patients in need, and we are pleased to report good progress with the FDA on achieving product release,” said Bill Lis, chief executive officer of Portola. “We are also continuing to advance AndexXa, the first-ever Factor Xa inhibitor antidote. This treatment is highly anticipated by the medical community and we are continuing discussions with U.S. and European regulatory authorities on our filings for this novel therapy.”

Recent Achievements, Upcoming Events and Milestones

Betrixaban -– an oral, once-daily Factor Xa inhibitor

Bevyxxa (betrixaban) received U.S. Food and Drug Administration (FDA) approval for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE
Committee for Medicinal Products for Human Use (CHMP) opinion anticipated by the end of 2017
Multiple abstracts accepted at the upcoming American Heart Association (AHA) and American Society of Hematology (ASH) (Free ASH Whitepaper) annual meetings
AndexXa (andexanet alfa) – a Factor Xa inhibitor antidote in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening bleeding or when urgent surgery is required; designated a Breakthrough Therapy and an Orphan Drug by the FDA

The FDA has set an action date of February 3, 2018 to respond to our Biologics License Application (BLA)
CHMP opinion anticipated in Q1 2018
Multiple abstracts accepted at the upcoming AHA and ASH (Free ASH Whitepaper) annual meetings
Corporate

Public offering successfully completed in September 2017, the net proceeds of which, including exercise of the underwriters’ over-allotment option, were $380.6 million.
Industry veteran John “Jack” Lawrence, M.D., appointed senior vice president and chief medical officer. Dr. Lawrence previously served as vice president and cardiovascular therapeutic area head for Bristol-Myers Squibb, including global responsibilities for apixaban.
Third Quarter 2017 Financial Results
Collaboration and license revenue earned under Portola’s collaboration and license agreements with Bristol-Myers Squibb Company, Pfizer, Bayer Pharma, Janssen Pharmaceuticals and Daiichi Sankyo was $3.8 million for the third quarter of 2017, compared with $9.3 million for the third quarter of 2016.

Total operating expenses for the third quarter of 2017 were $84.3 million, compared with $100.8 million for the same period in 2016. Total operating expenses for the third quarter of 2017 included $10.1 million in stock-based compensation expense, compared with $7.8 million for the same period in 2016.

Research and development expenses were $55.3 million for the third quarter of 2017, compared with $87.2 million for the third quarter of 2016. The decrease in R&D expenses was largely attributable to a $27.3 million one-time charge taken in the third quarter of 2016 resulting from the Company’s decision to suspend Line C manufacturing at CMC Biologics.

Selling, general and administrative expenses for the third quarter of 2017 were $28.9 million, compared with $13.6 million for the same period in 2016.

For the third quarter of 2017, Portola reported a net loss of $82.9 million, or $1.41 net loss per share, compared with a net loss of $92.9 million, or $1.64 net loss per share, for the same period in 2016.

Cash, cash equivalents and investments at September 30, 2017 totaled $597.8 million, compared with cash, cash equivalents and investments of $318.8 million as of December 31, 2016. The increase is due to the net proceeds of $380.6 million from the Company’s September 12, 2017 public offering.

If the FDA approves andexanet in Q1 2018, the Company will receive an additional $100 million from its royalty-based financing with Health Care Royalty Partners.

Conference Call Details
Portola will host a conference call today, Monday, November 6, 2017, at 4:30 p.m. Eastern Time, during which management will provide updates on the U.S. launch of Bevyxxa, third quarter 2017 financial results and other matters. The live call can be accessed by phone by calling (844) 452-6828 from the United States and Canada or (765) 507-2588 internationally and using the passcode 7269839. 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.

On November 6, 2017 Protagonist Therapeutics, Inc. (NASDAQ: PTGX) reported its financial results for the third quarter and nine months ended September 30, 2017 and provided an update on the company’s recent achievements (Press release, Protagonist, NOV 6, 2017, View Source [SID1234521610]).

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“We recently reported positive preliminary Phase I results for PTG-300, our hepcidin mimetic in development for the potential treatment of anemia and iron overload related blood disorders, including rare diseases such as beta-thalassemia and myelodysplastic syndromes (MDS). These results, coupled with the encouraging Phase I results achieved for PTG-100 in 2016 and the recent partnership with Janssen for PTG-200, all provide validation for our novel peptide platform,” said Dinesh Patel, president and chief executive officer. “We plan to continue to execute on our strategy of optimizing our peptide technology platform and applying it to the discovery and development of drugs that address unmet medical needs and offer strong differentiation against existing treatments.”

Recent Pipeline Achievements

· PTG-300: The company reported preliminary results from a Phase 1 clinical trial of PTG-300, the company’s hepcidin mimetic, which demonstrated pharmacodynamic proof-of-concept in normal healthy volunteers. This data indicated that PTG-300 demonstrated a dose-related reduction in serum iron, which persisted beyond 72 hours at higher dose levels. PTG-300 showed a dose-dependent increase in blood drug levels and was well tolerated with no serious adverse events or dose-limiting toxicities. The company expects to report final top-line results from the complete study in the fourth quarter of 2017.

· PTG-100: The ongoing Phase 2B trial in ulcerative colitis patients remains on track to report interim futility analysis in early 2018 and top-line results in the second half of 2018. In parallel, the company is making all the preparations needed to support Phase 3 development.

· PTG-200: The company closed a license and collaboration agreement with Janssen Biotech, Inc. for clinical development of PTG-200. PTG-200 is expected to enter a Phase 1 clinical trial in the fourth quarter of 2017.

On November 6, 2017 XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery, development and licensing of therapeutic antibodies, reported its third quarter 2017 financial results and recent business highlights (Press release, Xoma, NOV 6, 2017, View Source [SID1234521612]).

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“We made significant progress on multiple fronts executing our new business strategy, and in doing so we completely transformed the Company. The highlight events were clearly the license agreements we secured for both gevokizumab and our IL-1 beta intellectual property portfolio with Novartis. Our strategy was further reinforced with new license agreements for use of our proprietary phage display libraries for antibody discovery. We also received milestone payments from our extensive portfolio of partner-funded programs,” stated Jim Neal, Chief Executive Officer of XOMA. “These third quarter transactions have resulted in a completely revamped balance sheet and multiple years of projected cash runway. With more than two dozen partner-funded programs that have the potential to generate substantial additional milestone and royalty payments, we are very well positioned to deliver sustained growth in the years ahead and create long-term value for shareholders.”

Recent Business Highlights

XOMA made important progress positioning the Company for long-term strategic success:

Licensing the global commercial rights to gevokizumab, a novel anti-IL-1 beta allosteric monoclonal antibody, to Novartis. In a separate agreement, XOMA granted Novartis a license to its intellectual property covering the use of IL-1 beta targeting antibodies in the treatment of cardiovascular disease. Under these agreements, XOMA received $31 million in cash payments, including a $5 million equity investment. The Company is eligible to receive up to $438 million in development, regulatory and commercial milestones plus tiered high-single to mid-double-digit royalties on net sales of gevokizumab. XOMA is also eligible to receive low-single-digit royalties on canakinumab sales in cardiovascular indications, rising to mid-single-digit royalties under certain circumstances. In addition to the upfront payments, Novartis also settled XOMA’s €12 million debt to Servier, and extended the maturity date on the Company’s debt to Novartis from September 2020 to September 2022.
Entering into new non-exclusive license agreements with three separate companies, Tizona Therapeutics, Inc., Torch Biosciences, Inc., and LakePharma, for use of XOMA’s proprietary phage display libraries for antibody discovery. Under these agreements, the Company is eligible to receive development and regulatory milestone payments plus single-digit royalties on net sales of products.
Earning a $3 million milestone payment related to the clinical advancement of an anti-botulism product candidate the Company licensed to Nanotherapeutics, Inc., in 2015. In September 2017, XOMA received an initial cash payment of $250,000 related to the milestone. The remaining amounts of the milestone payment will be received in monthly payments over the next eleven months. If the product candidate advances from its current stage of development to production and stockpiling by governmental agencies, XOMA is eligible to receive a 15 percent royalty on net sales.
Continuing implementation of the Company’s previously announced aggressive corporate cost reduction plan.
Financial Results

XOMA recorded total revenues of $36.2 million for the third quarter of 2017, compared to $0.6 million for the third quarter of 2016. The increase in revenues for the third quarter of 2017 was due primarily to upfront payments received relating to the Company’s license agreements with Novartis in August 2017.

Research and development (R&D) expenses were $0.3 million for the third quarter of 2017, compared to $8.7 million for the third quarter of 2016. The decrease in R&D expenses for the third quarter of 2017 was due primarily to reductions of $3.5 million in salaries and related expenses, $1.8 million in external manufacturing activities, $1.2 million in the allocation of facilities and information technology costs, $0.9 million in clinical trial costs, and $0.4 million in consulting costs. The decrease in external manufacturing costs included a one-time adjustment of $0.7 million to reverse the cost of a batch of drug material that did not meet quality standards. The significant reduction in R&D spending year-over-year is a result of the execution of the Company’s corporate strategy of leveraging its extensive portfolio of partnered programs and licensed technologies.

General and administrative (G&A) expenses were $7.3 million for the third quarter of 2017, compared to $4.1 million for the third quarter of 2016. G&A expenses for the three months ended September 30, 2017, included increases of $1.9 million in consulting services primarily related to the Company’s license agreements with Novartis, $1.0 million in the allocation of facilities and information technology costs due to a greater proportion of general and administrative personnel after the Company’s restructuring activities, and $1.0 million in stock compensation cost, partially offset by a $0.6 million decrease in salaries and benefits.

Net income for the third quarter of 2017 was $26.3 million, compared to net loss of $12.5 million for the third quarter of 2016. The significant net income for the third quarter of 2017 was due primarily to the increase in total revenues previously discussed.

On September 30, 2017, XOMA had cash and cash equivalents of $47.7 million. The Company ended December 31, 2016, with cash and cash equivalents of $25.7 million. The Company’s current cash and cash equivalents are expected to be sufficient to fund its operations for multiple years.