On November 2, 2017 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and reported financial results for the third quarter ending September 30, 2017 (Press release, PTC Therapeutics, NOV 2, 2017, View Source [SID1234521522]).

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“Our performance this quarter combined with our commercial, financial and R&D advancements should allow us to end 2017 in a strong position,” said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. “Our commercial success is driven by our mission of improving the lives of patients with Duchenne.”

Third Quarter Financial Highlights:

Translarna net product sales were $32.0 million for the third quarter of 2017, representing 45% growth over $22.0 million reported in the third quarter of 2016.
EMFLAZA net product sales were $9.8 million for the third quarter of 2017.
Total revenues for the third quarter of 2017 were $41.9 million compared to $23.0 million in the same period of 2016. The change in total revenue was a result of the expanded commercial launch of Translarna and the successful U.S. EMFLAZA launch.
GAAP R&D expenses were $30.0 million for the third quarter of 2017 compared to $31.4 million for the same period in 2016. Non-GAAP R&D expenses were $26.4 million for the third quarter of 2017, excluding $3.6 million in non-cash, stock-based compensation expense, compared to $27.1 million for the same period in 2016, excluding $4.3 million in non-cash, stock-based compensation expense. The decrease in R&D expense for the third quarter of 2017 as compared to the prior year period was primarily due to the completion of our Phase 3 Translarna trials at the end of 2016 partially offset by start-up clinical activities and regulatory spend.
GAAP SG&A expenses were $31.4 million for the third quarter of 2017 compared to $23.7 million for the same period in 2016. Non-GAAP SG&A expenses were $27.9 million for the third quarter of 2017, excluding $3.5 million in non-cash, stock-based compensation expense, compared to $19.0 million for the same period in 2016, excluding $4.6 million in non-cash, stock-based compensation expense. The increase in SG&A expenses primarily related to the expansion of the U.S. commercial sales team in support of the launch of EMFLAZA.
Net interest expense for the third quarter of 2017 was $3.4 million compared to net interest expense of $2.1 million in the same period in 2016. The increase in net interest expense is primarily a result of increased interest expense related to the $40 million secured loan facility which we closed during the second quarter of 2017 partially offset by reduced interest income from investments.
Net loss for the third quarter of 2017 was $33.7 million compared to a net loss of $35.2 million for the same period in 2016.
Cash, cash equivalents, and marketable securities totaled approximately $169.3 million at September 30, 2017 compared to approximately $231.7 million at December 31, 2016.
Shares issued and outstanding as of September 30, 2017, were 41.5 million, which includes 0.1 million shares of unvested restricted stock awards.
2017 Guidance:

Translarna net sales guidance for 2017 is anticipated to be between $120 and $140 million. We now anticipate EMFLAZA net sales for 2017 to be between $20 and $25 million, an increase from our prior guidance of $15 to $20 million. This brings 2017 full year revenue guidance between $160 and $185 million, an increase from our prior guidance of $155 million to $180 million, including a $20 million milestone we achieved in mid-October, under our SMA program.
GAAP R&D and SG&A expense for the full year 2017 are now anticipated to be between $250 to $260 million. Excluding estimated non-cash, stock-based compensation expense of approximately $40 million, full year 2017 non-GAAP R&D and SG&A expense are now anticipated to be between $210 million and $220 million. These expenses will be primarily in support of the commercial availability of Translarna globally, the commercial launch of EMFLAZA in the U.S. and the continued research and clinical development of other product pipeline candidates.
We now expect to end 2017 with over $150 million of cash and cash equivalents, an increase from prior guidance of $120 million.
Key Third Quarter and other Corporate Highlights:

Filed Formal Dispute Resolution Request with U.S. FDA to appeal Complete Response Letter for ataluren. PTC received a Complete Response Letter from the Office of Drug Evaluation I of the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of the investigational medicine ataluren for the treatment of nonsense mutation dystrophinopathies. The letter stated that it is unable to approve the application in its current form. PTC has filed a formal dispute resolution request challenging this decision.
EMFLAZA revenue grew to $9.8M in third quarter. PTC is committed to enabling access to EMFLAZA for all patients in need, regardless of financial situation or insurance status. We demonstrated an increase in EMFLAZA prescriptions over the past quarter. There are currently over 1,500 patients on EMFLAZA and we estimate that there are approximately 9,000 Duchenne patients in the U.S. over the age of five who are eligible to be prescribed EMFLAZA.
Continued global expansion of Translarna results in revenue of $32.0M in third quarter. PTC continues to expand its strong global footprint, with sales generated in over 25 countries. This strong performance reflects continued uptake, sustainable pricing levels, and high ( > 90%) compliance to treatment.
SMA clinical program advanced into the pivotal portion of the study. In mid-October, the SUNFISH trial transitioned into the pivotal portion of the study which triggered a $20M milestone to PTC from Roche. Data from the SUNFISH trial was presented at the International Congress of the World Muscle Society. An interim analysis of the five cohorts treated with RG7916 for 28 days demonstrates an exposure-dependent increase in SMN protein.
Non-GAAP Financial Measures:
In this press release, the financial results and financial guidance of PTC are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, non-GAAP financial measures exclude stock-based compensation expense and one-time restructuring expenses relating to the reorganization of operations intended to improve efficiency and better align costs and employment structure with PTC’s strategic plans. These non-GAAP financial measures are provided as a complement to results reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management’s opinion, these non-GAAP financial measures are useful to investors and other users of PTC’s financial statements by providing greater transparency into the operating performance at PTC and the company’s future outlook. Quantitative reconciliations of GAAP financial measures are included in the tables below

On November 2, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported financial results for the third quarter ended September 30, 2017 (Press release, Loxo Oncology, NOV 2, 2017, View Source [SID1234521483]).

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“In recent months, we have announced meaningful progress across our TRK and RET programs,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. “For larotrectinib, an independent review committee has corroborated the striking response rate reported at ASCO (Free ASCO Whitepaper). These data will anchor global regulatory submissions, including a U.S. submission which is on track for late 2017 or early 2018. For RET, study investigators provided a first look at LOXO-292’s potential at the recent World Lung meeting in Japan. The LOXO-292 Phase 1 trial continues to enroll well, and we look forward to providing a study update in 2018.”

Recent Highlights

Larotrectinib

Independent Review Committee Assessment of Larotrectinib Dataset: On October 18, 2017, Loxo Oncology announced top-line overall response rate (ORR) results from the independent review committee assessment of the larotrectinib dataset. Consistent with global written regulatory correspondence, this dataset includes adult and pediatric tropomyosin receptor kinase (TRK) fusion patients enrolled in Loxo Oncology’s Phase 1 adult trial, Phase 2 trial (NAVIGATE), and Phase 1/2 pediatric trial (SCOUT). The dataset is based on the intent to treat (ITT) principle, using the first 55 TRK fusion patients with RECIST-evaluable disease enrolled to the three clinical trials, regardless of prior therapy or tumor tissue diagnostic method. The primary endpoint for the integrated analysis of efficacy is ORR according to the independent review committee assessment, as measured by RECIST v1.1. A key secondary endpoint is ORR according to local investigator assessment, as measured by RECIST v1.1. As of a July 17, 2017 data cut-off date, the ORR was 75% by independent review and 80% by investigator assessment. An overview of the topline data can be found here.
Updated Pediatric Data to Be Presented: Updated pediatric data have been accepted for presentation at the Connective Tissue Oncology Society (CTOS) Annual Meeting on November 10, 2017, and at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pediatric Cancer Research on December 4-5, 2017. At CTOS, larotrectinib investigators will present an update on the pediatric patients treated with larotrectinib prior to surgical resection. At the AACR (Free AACR Whitepaper) Special Conference on Pediatric Cancer Research, larotrectinib investigators will present updated data from the pediatric dataset last presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June.
Data to be Presented at American Society of Hematology (ASH) (Free ASH Whitepaper). At the 59th Annual ASH (Free ASH Whitepaper) Meeting taking place December 9-12, 2017 in Atlanta, GA, Loxo Oncology and academic collaborators will present an abstract regarding TRK fusions in hematologic malignancies.
LOXO-292

Proof-of-Concept Clinical Data in RET Fusion Lung Cancer: On October 18th, LOXO-292 trial investigators presented initial clinical data from the program at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer. This presentation primarily described the first two patients with RET-fusion lung cancer with and without brain metastases treated with LOXO-292. Both patients had disease progression while receiving prior multi-kinase inhibitors. On single agent LOXO-292, both patients achieved RECIST confirmed partial responses and remain on LOXO-292 as of the September 27, 2017 data cut-off of the presentation. In this early, two-patient dataset, LOXO-292 has been well-tolerated, with no adverse events attributed to LOXO-292. Additionally, the presentation included pharmacology evidence that the Phase 1 dose level of 60mg twice daily provides IC90 RET target coverage in patients. The presentation can be viewed here. Loxo Oncology plans to present additional clinical data from this program in the first half of 2018.
Upcoming Milestones

Larotrectinib (TRK)
Medical meeting presentations in the fourth quarter of 2017 include the CTOS Annual Meeting, AACR (Free AACR Whitepaper) Special Conference on Pediatric Cancer Research, and ASH (Free ASH Whitepaper)
Submission of larotrectinib NDA expected by year end 2017 or early 2018
Updated integrated TRK fusion clinical data publication and/or presentation expected in the first half of 2018
LOXO-195 (next-generation TRK)
Clinical data presentation expected in 2018
LOXO-292 (RET)
Clinical data presentation expected in the first half of 2018
LOXO-305 (BTK)
Phase 1 clinical trial initiation expected in 2018
Third Quarter 2017 Financial Results

As of September 30, 2017, Loxo Oncology had aggregate cash, cash equivalents and investments of $405.3 million, compared to $141.8 million as of December 31, 2016.

Research and development expenses were $64.8 million for the third quarter of 2017 compared to $14.2 million for the third quarter of 2016. This increase was primarily due to a non-recurring charge related to the $40.0 million asset acquisition of the BTK inhibitor program from Redx Pharma Plc and Redx Oncology Limited (collectively, “Redx”), expanded larotrectinib development activities including clinical costs and costs related to the companion diagnostics agreement with Roche, as well as additional development expenses related to our other programs. Loxo Oncology also recognized research and development-related stock-based compensation expense of $2.1 million during the third quarter of 2017 compared to $1.6 million for the third quarter of 2016.

Research and development expenses were $109.3 million for the nine months ended September 30, 2017, compared to $34.9 million for the nine months ended September 30, 2016. This increase was primarily due to a non-recurring charge related to the $40.0 million asset acquisition of the BTK inhibitor program from Redx, expanded larotrectinib development activities including clinical costs and costs related to the companion diagnostics agreement with Roche, as well as additional development expenses related our other programs. We also had higher employment costs primarily due to increased headcount. Loxo Oncology also recognized research and development-related stock-based compensation expense of $8.0 million during the nine months ended September 30, 2017, compared to $2.1 million for the nine months ended September 30, 2016.

General and administrative expenses were $9.7 million for the third quarter of 2017 compared to $3.7 million for the third quarter of 2016. The increase was primarily due to increases in preparation activities for the potential commercialization of larotrectinib, headcount and employment costs and general and administrative professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $3.1 million during the third quarter 2017 compared to $1.2 million for the third quarter of 2016.

General and administrative expenses were $21.0 million for the nine months ended September 30, 2017, compared to $10.9 million for the nine months ended September 30, 2016. The increase was primarily due to increases in preparation activities for the potential commercialization of larotrectinib, headcount and employment costs and general and administrative professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $6.7 million during the nine months ended September 30, 2017, compared to $3.3 million for the nine months ended September 30, 2016.

Net loss was $73.3 million and $128.2 million for the three and nine months ended September 30, 2017, respectively, compared to $17.7 million and $45.2 million for the three and nine months ended September 30, 2016, respectively.

Non-GAAP net loss was $28.1 million and $73.6 million for the three and nine months ended September 30, 2017, respectively, compared to $14.9 million and $39.8 million for the three and nine months ended September 30, 2016, respectively. This non-GAAP net loss measure, more fully described below under “Non-GAAP Financial Measures,” excludes the acquisition of an in process R&D asset and share-based compensation expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

Conference Call Information
Loxo Oncology will host a conference call today at 8:00 a.m. ET to discuss the third quarter 2017 financial results and program updates. To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 78661148. A replay will be available shortly after the conclusion of the call and archived on the company’s website for 30 days following the call.

Progenics Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Progenics Pharmaceuticals, 2017, NOV 2, 2017, View Source [SID1234521499]).

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On November 2, 2017 Sanofi presents Q3 2017 Results (Press release, Sanofi, NOV 2, 2017, View Source [SID1234521456])

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On November 2, 2017 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA, TASE: TEVA) reported results for the quarter ended September 30, 2017 (Press release, Teva, NOV 2, 2017, View Source [SID1234521491]).

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Revenues in the third quarter of 2017 were $5.6 billion, up 1% compared to the third quarter of 2016. Excluding the impact of foreign exchange fluctuations, revenues increased 4%.

Exchange rate differences between the third quarter of 2017 and the third quarter of 2016 reduced revenues by $169 million, GAAP operating income by $32 million and non-GAAP operating income by $17 million.

Adjustments of the exchange rates used for the Venezuelan bolivar resulted in a decrease of $243 million in revenues, a decrease of $25 million in GAAP operating income and a decrease of $15 million in non-GAAP operating income, compared to results in the third quarter of 2016. In light of the political and economic conditions in Venezuela, we exclude the quarterly changes in revenues and operating profit in Venezuela from any discussion of local currency results.

GAAP gross profit was $2.6 billion in the third quarter of 2017, down 6% compared to the third quarter of 2016. GAAP gross profit margin was 47.1% in the third quarter of 2017, compared to 50.4% in the third quarter of 2016. Non-GAAP gross profit was $3.0 billion in the third quarter of 2017, a decline of 12% from the third quarter of 2016. Non-GAAP gross profit margin was 53.0% in the third quarter of 2017, compared to 61.0% in the third quarter of 2016. The decrease in gross profit margin, on both a GAAP and a non-GAAP basis, was the result of lower gross profit and profitability of both our generic medicines and our specialty medicines businesses, as well as the addition of the low-margin Anda distribution business. GAAP results were impacted by lower inventory step-up expenses and lower amortization expenses, which mitigated some of the decrease.

Research and Development (R&D) expenses for the third quarter of 2017 amounted to $545 million, down 18% compared to the third quarter of 2016 due to lower expenditure related both to generic and specialty medicines as well as lower other R&D expenses. R&D expenses excluding equity compensation expenses and other R&D expenses were $381 million, or 6.8% of quarterly revenues in the third quarter of 2017, compared to $406 million, or 7.3%, in the third quarter of 2016. R&D expenses related to our generic medicines segment were $162 million, a decrease of 12% compared to $185 million in the third quarter of 2016, mainly due to portfolio optimization and various efficiency measures. R&D expenses related to our specialty medicines segment were $217 million, a decrease of 5% compared to $228 million in the third quarter of 2016, mainly due to portfolio optimization activities which compensated for the increased expenses related to our late-stage product candidates.

Selling and Marketing (S&M) expenses in the third quarter of 2017 amounted to $860 million, a decrease of 9% compared to the third quarter of 2016. S&M expenses excluding amortization of purchased intangible assets and equity compensation expenses were $805 million, or 14.3% of revenues, in the third quarter of 2017, compared to $889 million, or 16.0% of revenues, in the third quarter of 2016. S&M expenses related to our generic medicines segment were $377 million, a decrease of 11% compared to $423 million in the third quarter of 2016, mainly due to lower expenses in Venezuela following exchange rate adjustments as well as certain efficiency measures, partially offset by the inclusion of the S&M expenses of the Actavis Generics business for a full quarter. S&M expenses related to our specialty medicines segment were $388 million, down 15% compared to $458 million in the third quarter of 2016, mainly due to cost reduction and efficiency measures in our commercial operations, aligning with the life cycle of our product portfolio.

General and Administrative (G&A) expenses in the third quarter of 2017 amounted to $330 million, compared to $310 million in the third quarter of 2016. G&A expenses excluding equity compensation expenses were $318 million in the third quarter of 2017, or 5.7% of quarterly revenues, compared to $304 million, or 5.5% in the third quarter of 2016.

GAAP operating income in the third quarter of 2017 was $378 million, compared to operating income of $765 million in the third quarter of 2016. Non-GAAP operating income in the third quarter of 2017 was $1.5 billion, a decrease of 18% compared to the third quarter of 2016. Non-GAAP operating margin was 26.2% in the third quarter of 2017 compared to 32.2% in the third quarter of 2016.

EBITDA (non-GAAP operating income, which excludes amortization and certain other items, as well as excluding depreciation expenses) was $1.6 billion in the third quarter of 2017, down 16% compared to $1.9 billion in the third quarter of 2016.

GAAP financial expenses for the third quarter of 2017 were $259 million, compared to $150 million in the third quarter of 2016. Non-GAAP financial expenses were $229 million in the third quarter of 2017, compared to $151 million in the third quarter of 2016. The increase in our non-GAAP financial expenses is due mainly to higher expenses related to net foreign exchange losses and financial derivatives, as well as higher interest expenses related to the debt raised to finance the acquisition of Actavis Generics.

GAAP income taxes for the third quarter of 2017 amounted to a benefit of $494 million. In the third quarter of 2016, income taxes amounted to $207 million, or 34% on pre-tax income of $615 million. Non-GAAP income taxes for the third quarter of 2017 amounted to $135 million on pre-tax non-GAAP income of $1.2 billion, for a quarterly tax rate of 11%. Non-GAAP income taxes in the third quarter of 2016 amounted to $261 million on pre-tax non-GAAP income of $1.6 billion, for a quarterly tax rate of 16%.

We expect our annual non-GAAP tax rate for 2017 to be 15%, lower than our previous estimates. This is due to changes in the geographical mix of income we expect to generate this year. Our non-GAAP tax rate for 2016 was 17%.

GAAP net income attributable to ordinary shareholders and GAAP diluted EPS were $530 million and $0.52, respectively, in the third quarter of 2017, compared to $348 million and $0.35, respectively, in the third quarter of 2016. Non-GAAP net income attributable to ordinary shareholders for calculating diluted EPS and non-GAAP diluted EPS were $1.0 billion and $1.00, respectively, in the third quarter of 2017, compared to $1.4 billion and $1.31 in the third quarter of 2016.

For the third quarter of 2017, the weighted average outstanding shares for the fully diluted earnings per share calculation on both a GAAP and a non-GAAP basis was 1,017 million. For the third quarter of 2016, this was 984 million shares on a GAAP basis, and 1,044 million shares on a non-GAAP basis. For the three months ended September 30, 2017, the mandatory convertible preferred shares amounting to 59.4 million weighted average shares, had an anti-dilutive effect on earnings per share and were therefore excluded from the outstanding shares calculation.

As of September 30, 2017, the fully diluted share count for calculating Teva’s market capitalization was approximately 1,083 million shares.

Non-GAAP information: Net non-GAAP adjustments in the third quarter of 2017 were $482 million. Non-GAAP net income and non-GAAP EPS for the quarter were adjusted to exclude the following items:

Impairment of long-lived assets of $408 million, mainly an impairment of product rights and R&D assets related to the Actavis Generics acquisition;
Amortization of purchased intangible assets totaling $357 million, of which $310 million is included in cost of goods sold and the remaining $47 million in selling and marketing expenses;
Other R&D expenses of $150 million;
Restructuring expenses of $72 million;
Acquisition, integration and related expenses, including contingent consideration, of $49 million;
Equity compensation expenses of $32 million;
Financial expenses of $30 million;
Other non-GAAP items of $44 million;
Legal settlements and loss contingencies benefit of $20 million;
Minority interest adjustment of negative $11 million; and
Tax benefit of $629 million, including the effect of a one- time tax benefit associated with the utilization of Actavis Generics historic capital losses.
Teva believes that excluding such items facilitates investors’ understanding of its business. See the attached tables for a reconciliation of the GAAP results to the adjusted non-GAAP figures. Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.

Cash flow from operations generated during the third quarter of 2017 was $1.1 billion, compared to $1.5 billion in the third quarter of 2016. The decrease was mainly due to the impact of changes in working capital which increased by $0.3 billion.

Free cash flow, excluding net capital expenditures, was $0.9 billion, compared to $1.2 billion in the third quarter of 2016.

Total balance sheet assets amounted to $86.1 billion as of September 30, 2017, compared to $86.4 billion as of June 30, 2017.

As of September 30, 2017, our debt was $34.7 billion, compared to $35.1 billion at June 30, 2017. The decrease was mainly due to $0.6 billion of debt repayments of our 5 year term loan, our revolving credit facility and other short term loans, partially offset by foreign exchange fluctuations of $0.2 billion. The portion of total debt classified as short-term at September 30, 2017 was 8%.

Total shareholders’ equity was $30.3 billion as of September 30, 2017, compared to $29.6 billion as of June 30, 2017.

Segment Results for the Third Quarter 2017

Beginning in the fourth quarter of 2016, our OTC business, conducted primarily through PGT, is included in our generic medicines segment. This segment also includes chemical and therapeutic equivalents of originator medicines in a variety of dosage forms and our API manufacturing business.

All data presented has been conformed to the new segment structure.